Category: Navigating Regulatory Landscapes in Latin America

Figures cited from the live ClinicalTrials.gov record NCT07085741 (study first posted 25 July 2025; last update posted 11 September 2026) and the published bioaccess® Mexico country page, verified 11 September 2026. General information, not legal or regulatory advice. Confirm current COFEPRIS, ethics-committee, and FDA rules with qualified advisers. We name only the facility and the trial those sources support. We do not publish site contact emails or phone numbers here. GT Metabolic Solutions is not claimed as a bioaccess® client. bioaccess® is not listed on this NCT.

If you searched Corporativo Hospital Satélite clinical trial, Hospital Satelite Naucalpan MAGNET, GT Metabolic Mexico duodeno-ileostomy, MAGNET 2 Study Mexico, or “go direct to the Naucalpan site,” you followed a facility string ClinicalTrials.gov still publishes on NCT07085741. Corporativo Hospital Satelite in Naucalpan, Mexico is a real named facility on that record. It is not the operator of the COFEPRIS file.

bioaccess®’s position is simple and it is not adversarial: Corporativo Hospital Satelite is the site. The First-in-Human CRO still owns COFEPRIS, institutional ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if Naucalpan is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. A completed location row does not become a CRO.

This page is for the Naucalpan / Hospital Satélite query. It does not repeat clinical trials in Mexico. That page stays the country operating system. Sibling Mexican pages stay on their own buildings: Especialistas de la Piel y Cirugía Monterrey, New Hope Fertility Centre Mexico City, and Reina Madre Mexico City. They are separate from this page.

Why the hospital name wins the search — and why that is not a CRO

NCT07085741 is an industry device listing. The registry’s own dates, retrieved 11 September 2026: study first submitted 8 April 2025; QC submitted 18 July 2025; first posted 25 July 2025; last update submitted 9 September 2026; last update posted 11 September 2026. Brief title: Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System in Mexico. Official title ends with the sponsor acronym MAGNET 2 Study. Organization study ID: GTM-002. Lead sponsor: GT Metabolic Solutions, Inc., class INDUSTRY, responsible party the sponsor. No collaborator is listed. No CRO is listed.

Design on the 11 September 2026 snapshot: interventional; intervention model description on the record says an open-label multicenter plan for up to 25 subjects at up to 3 study centers in Mexico; allocation N/A; no masking; primary purpose treatment; phase N/A; actual enrollment 10; status COMPLETED. Actual start 7 May 2025; actual primary completion 19 October 2025; actual completion 21 June 2026. Conditions: obesity; type 2 diabetes. The brief summary’s own words: evaluate the feasibility / performance, safety and initial efficacy of the MAGNET System, DI Biofragmentable for side-to-side duodeno-ileostomy diversion.

Intervention, in the registry’s words: a device — MAGNET System, DI Biofragmentable; anastomoses achieved by magnetic compression. Primary outcomes listed: magnet placement (≥90% alignment during the index procedure); natural magnet passage without surgical re-intervention through 90 days; anastomosis patency confirmed radiologically through 90 days. The registry’s oversight module records no data monitoring committee, and marks the study as not FDA-regulated drug and not FDA-regulated device — a sponsor-entered flag about this listing, not a statement about what a later U.S. filing would require.

Location rows currently published:

• Corporativo Hospital Satelite — the only location on the record — Naucalpan, Mexico. No site contact or overall official is printed on the public row as of the 11 September 2026 snapshot. We will not invent a principal investigator name.

Read the record as it is. A single Mexican facility string, an actual enrollment of 10, feasibility language in the brief summary, an industry sponsor, and no CRO in the public copy. That is the search gap: a sponsor searching MAGNET System Mexico, GT Metabolic Naucalpan, or Hospital Satélite metabolic anastomosis now lands on a named hospital with no operator between them and the file. MAGNET 2 naming and earlier MagDI listings elsewhere on ClinicalTrials.gov mean we will not invent a “world’s first implant” claim for this page; the page is the Mexico facility string, not a global first-case press release.

Naucalpan is a site. The CRO is the operator.

A Naucalpan hospital campus can provide operating rooms, metabolic/bariatric procedural capacity, imaging for anastomosis patency, and local research staffing when contracted. That is necessary. It is not sufficient for an investigational-device study a U.S. board expects to survive later scrutiny.

What a site can typically do when a sponsor “goes direct”:

• Discuss investigator interest and procedural feasibility for a magnetic-anastomosis protocol — when that service is available and appropriate for your device, which is not automatic.
• Share institutional ethics-committee calendars and hospital research rules.
• Quote procedure, visit, and local staffing costs for the cases they will physically run.

What the site is not built to own for an investigational device:

• COFEPRIS. Clinical investigations sit under the Ley General de Salud and its implementing regulations. The submission is in Spanish: protocol, investigator brochure, informed consent, ethics approval, proof of insurance. A conversation with a Naucalpan hospital is not that dossier.
• Institutional ethics. Ethics-committee review under NOM-012-SSA3-2012 sits in front of the COFEPRIS file, and the committee is tied to the host institution once the site is chosen.
• Investigational import. Bringing an unapproved device into Mexico is a separate workstream from the trial authorization and from a later commercial registro sanitario. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a site-only premium here.
• ISO 14155 monitoring, EDC, adverse-event reporting, and the TMF.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after the GCP and ethics documentation that rule defines. Eligibility is not clearance. See OUS FIH and FDA IDE.
• Multi-country optionality. If one Mexican campus is not enough, a single-hospital MSA will not stretch to Colombia, Panama, Chile, or Brazil.

Going direct to Corporativo Hospital Satelite is how you confirm a room. It is not how you open an investigational file.

Site versus CRO

Workstream	What the Naucalpan hospital (site) typically owns	What the CRO still owns
Procedure	OR, magnetic placement session, local imaging and staff	Protocol fit, training, device accountability
Ethics	Institutional committee calendar and local rules	Packet, ICF, IB alignment, deficiency cycle (NOM-012-SSA3-2012)
National authority	Not the permit holder by being listed on an NCT	COFEPRIS clinical-investigation file, in Spanish
Import	Receiving and storage if contracted	Importer of record for the investigational system
Quality	Hospital quality and the index procedure	ISO 14155 monitoring, EDC, AE reporting, TMF
FDA conversation	Source documents from cases they run	21 CFR 812.28 narrative — eligibility, not clearance
Country optionality	One Naucalpan campus	Colombia (INVIMA) and the rest of the bioaccess® platform

How COFEPRIS and ethics sit next to the hospital

Use clinical trials in Mexico for the full pathway. Facts a sponsor searching this facility needs on one screen, already published there and not re-averaged here:

• Ethics committee review under NOM-012-SSA3-2012 comes first, then COFEPRIS review; the calendar is confirmed per protocol.
• Published per-patient range $18,000–$30,000; 10+ pre-qualified sites across Mexico City, Guadalajara, and Monterrey.
• The ~30-working-day COFEPRIS figure is registro sanitario / vía abreviada — a commercial market-access clock, not this trial clock.
• All COFEPRIS submissions are in Spanish, including protocol, investigator brochure, and informed consent.
• Under 21 CFR 812.28, foreign clinical data is eligible for FDA submission and review when the investigation meets that rule’s GCP conditions. Eligibility is not a guarantee of clearance or approval.
• bioaccess®’s published cost comparison versus a typical U.S. or EU program is an experience-based estimate from work since 2010, not a formal study.

We will not invent a facility-only day count. Ask for a protocol-specific calendar. A hospital email is not a COFEPRIS authorization.

What the GT Metabolic public file actually supports — and what it does not

• Device: MAGNET System, DI Biofragmentable (magnetic side-to-side duodeno-ileostomy anastomosis), as described on NCT07085741.
• Sponsor: GT Metabolic Solutions, Inc. (industry). No collaborator. No CRO named.
• Site: Corporativo Hospital Satelite, Naucalpan, Mexico — the only location row on the 11 September 2026 snapshot.
• Design: interventional, phase N/A; actual n=10; COMPLETED; actual start 7 May 2025; actual completion 21 June 2026; brief summary uses feasibility / performance language; official title labels the file MAGNET 2 Study (org ID GTM-002).
• Named investigator (as published): none on the public location or overall-official fields as of this snapshot. We do not invent one.
• Not claimed here: that the NCT named bioaccess®; that GT Metabolic is a bioaccess® client; that we have MAGNET outcomes; that this listing is an FDA IDE; that the hospital holds a COFEPRIS authorization because it is printed on a registry row; that this Mexico row is the world’s first MagDI implant.

What the CRO still does after you have a hospital name

• Regulatory-fit, not tourism. Mexico is a sourced device geography. It is not automatically the right country for every indication. bioaccess® still runs clinical trials in Colombia and the rest of the platform.
• Protocol, IB, ICF, insurance, and the COFEPRIS / ethics packet — in Spanish.
• Importer of record and device accountability for the investigational system.
• ISO 14155 monitoring and the 21 CFR 812.28 narrative for a later FDA conversation.
• Optionality if one Estado de México campus is not enough.

The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™. Background on why registry rows keep outranking operators: ClinicalTrials.gov FIH sites vs the CRO.

Frequently asked questions

Can I contract Corporativo Hospital Satelite directly?

You can try. The facility can discuss investigator interest, local procedure costs, and ethics-committee calendars. It cannot become your COFEPRIS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager because GT Metabolic listed Naucalpan. Contract the CRO; let the CRO activate the site.

Did bioaccess® run the MAGNET 2 study?

No public bioaccess® page says so. We will not invent that claim. This page answers the search; it does not claim the study.

The registry says this is not an FDA-regulated device study. Does 21 CFR 812.28 still matter?

It matters the moment you want the data to travel. That sponsor-entered flag describes this listing. If a U.S. submission is ever the goal, the GCP, ethics, and documentation conditions in 21 CFR 812.28 are what make foreign data eligible for FDA submission and review — and eligibility is still not clearance.

Is this a first-in-human study?

The brief summary uses feasibility / performance language and the official title calls the file MAGNET 2 Study. Earlier MagDI / MAGNET System listings for GT Metabolic exist on ClinicalTrials.gov outside Mexico. We cover the Naucalpan facility string; we do not invent a global first-implant headline from this NCT alone.

Is Colombia still an option?

Yes. bioaccess® still runs trials in Colombia. A Naucalpan search is not an instruction to abandon INVIMA. See CRO in Colombia.

Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current INVIMA, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Clinica INO Bogotá as a bioaccess® client.

If you searched Clinica INO Bogota first-in-human, Clinica INO Bogotá clinical trial, Clinica INO CRO, Clinica INO compression stockings, or “go direct Clinica INO Bogotá,” you followed a campus string ClinicalTrials.gov still publishes. Clinica INO in Bogotá, Colombia, is a real named clinic-campus string on ClinicalTrials.gov. The two public DEVICE rows on this string are borderline aesthetic/device work (graduated compression stockings / air-travel after aesthetic surgery) — still a search gap, not a CRO. It is not a first-in-human medical-device CRO, and it is not the operator of the INVIMA file.

bioaccess®’s position is simple and it is not adversarial: the clinic is the site. The First-in-Human CRO still owns INVIMA, accredited ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the clinic still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Bogotá Clinica INO campus. It is DISTINCT from Fundación Reumatología Fernando Chalem Bogotá, Clínica del Country Bogotá, Fundación CTIC Bogotá, Fundación Neumológica Colombiana Bogotá, Fundación Cardioinfantil Bogotá, and Fundación Santa Fe de Bogotá. Sharing Bogotá is not a license to collapse them. Clinica INO is not Chalem. Clinica INO is not Country. Clinica INO is not CTIC. bioaccess® runs first-in-human studies in Colombia now.

Why the campus name wins the search — and why that is not a CRO

Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years), this campus sits here after filters:

Counts are unique NCT IDs from a ClinicalTrials.gov sweep of Latin American facilities pulled 1 September 2026.

• Clinica INO (Bogotá, Colombia) — canonical NCT string: ALL interventional n=2; DEVICE n=2. Example NCT IDs: NCT07808931, NCT07810192.

bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. The DEVICE n=2 rows are borderline aesthetic/device (graduated compression stockings / air-travel after aesthetic surgery).

Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this clinic as a client site.

That is the leak: a founder searching Clinica INO Bogotá first-in-human finds ALL n=2 (DEVICE n=2) without finding INVIMA. Borderline aesthetic/device rows (graduated compression stockings / air-travel after aesthetic surgery) still put a campus string in front of a CRO. A named clinic is still a site. An NCT location row is not a CRO.

The site is the site. The CRO is the operator.

A named clinic can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

What the clinic can typically do when a sponsor “goes direct”:

• Discuss investigator interest and whether a protocol can sit in an existing service line.
• Share institutional ethics-committee calendars and hospital research rules.
• Quote visit, staffing, and local procedure costs for the cases they will physically run.

What the clinic is not built to own for an investigational device:

• INVIMA. INVIMA is the national file for an investigational device in Colombia. Resolución 8430/1993 still sits on the ethics and research side of that stack. A hallway conversation on this campus is not the INVIMA dossier. Resolución 2378 does not govern device clinical trials — see the live country pages rather than importing a drug-GCP resolution onto a device file. A hallway conversation at Clinica INO is not a Chalem file, not a Country file, and not a CTIC file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

How INVIMA actually works (the short version)

Use CRO in Colombia. Colombia ethics timing depends on each committee’s meeting schedule. Published comparison already on the Panama country page: per-patient $15,000–$25,000. bioaccess® still runs clinical trials in Colombia — local entity, INVIMA clocks in-country. We pick the country the device needs. A hospital email in Bogotá is not INVIMA clearance.

Ask for a protocol-specific calendar. A hospital email is not INVIMA clearance. bioaccess® manages the file. That is CRO work, not site work.

All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

Not a critique of the hospital

Clinica INO is a serious named Bogotá campus on the public registry. ALL n=2 and DEVICE n=2 are registry volume, not a punchline — including the borderline aesthetic/device compression-stocking rows. This is not a critique of the clinic. Use the site when the protocol fits. Hire the operator. bioaccess® runs first-in-human studies in Colombia now.

What the CRO still does after you have the campus on a slide

1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
2. Protocol, IB, ICF, insurance, and the INVIMA / ethics packet.
3. Importer of record and device accountability.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

The firm was founded in 2010. That is the operator layer around a campus string.

Colombia is still on the map

Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. Ethics review in both Panama and Colombia runs on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Clinica INO Bogotá directly for a device FIH?

You can try. The clinic can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your INVIMA applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

Did bioaccess® run the NCT IDs listed here?

No public bioaccess® case-study page names this clinic. We will not invent that claim. This page answers the search; it does not claim the studies.

Is this the same page as Fundación Reumatología Fernando Chalem or Clínica del Country Bogotá?

No. Fundación Reumatología Fernando Chalem Bogotá has its own page. Clínica del Country Bogotá has its own page. Fundación CTIC Bogotá has its own page. This page is Clinica INO only.

Does bioaccess® run first-in-human studies in Colombia?

Yes. The public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia — and Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. We pick the country the device needs.

Are NCT07808931 and NCT07810192 classic implant FIH programs?

No claim of that. Public rows on this campus string are borderline aesthetic/device (graduated compression stockings / air-travel after aesthetic surgery). They still create a direct search path to the site. We cite them as facility evidence only.

Did bioaccess® run NCT07808931 or NCT07810192?

No. We cite them as facility evidence. We will not invent a sponsor or a PI. We will not claim bioaccess® ran these studies.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Bogotá sibling (do not merge): Fundación Reumatología Fernando Chalem Bogotá.

Julio G. Martinez-Clark, CEO · bioaccess®

General information, not legal or regulatory advice. Confirm current agency, holder, import, and post-market rules with qualified advisers. We do not invent Pure Global, freelancer, or competitor rates. bioaccess® pricing is the two-part model published on market-access: a one-time registration fee, then an annual holder fee from year 2. No unpublished client. No PHI. Always bioaccess®.

If you searched Brazil RA consultant medical device, ANVISA regulatory consultant, or Brazil regulatory affairs consultant medical device, you were looking for advice that is often mistaken for the BRH / detentor / ANVISA operator stack. This page owns that search intent: BRH stack vs freelance advice. It does not name freelancers. No PHI. Always bioaccess®.

The leak: a consultant who drafts ANVISA dossiers, advises on classification, or coaches RDC language is still not the ethics calendar + IOR + site network + inspection-ready ops stack — and for commercial devices is still not the Brazilian Registration Holder (BRH / detentor) named on the certificate. bioaccess® is the LATAM FIH CRO and local RA / IOR operator that owns that stack.

What the search usually means vs what execution requires

• Search intent often means: someone who “knows ANVISA” for cadastro/registro, BGMP awareness, or clinical submission coaching under RDC 837/2023.
• Execution requires: Portuguese dossier discipline; CEP ethics capped on live Brazil hubs; ANVISA trial authorization where applicable; investigational or commercial import entity; sites that enroll; or, for commercial SKUs, BRH / detentor on the certificate plus IOR on the entry.
• A freelance ANVISA RA retainer usually covers: gap assessment, dossier outline, and meeting prep — not BRH ownership and not ISO 14155 monitoring.
• Do not collapse: INMETRO / ANATEL homologation, BGMP audit pass-through, and BRH into one “Brazil RA” invoice line without reading the holder hub.

ANVISA / BRH stack: trial vs commercial

Use Clinical Trials in Brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000 on that hub. Trial authorization and later market registration are separate workstreams. We will not invent a new ANVISA clock on this page.

Commercial BRH / IOR: Brazil ANVISA Registration Holder / IOR (BRH / Detentor). Brazil pricing: a one-time registration fee of $6,750 (Class I/II) or $22,250 (Class III/IV), then an annual holder fee from year 2 of $6,000 (Class I/II) or $7,500 (Class III/IV) (rate card). BGMP manufacturing-site audit and INMETRO are separate lines. Trial IOR: importer of record for clinical trial devices.

BRH stack vs freelance advice

1. Who is the detentor / BRH? ANVISA names a Brazilian legal entity on the registration. A consultant who helps you appoint is not the detentor.
2. Who owns Portuguese sworn pages where required? Ask each vendor before you compare quotes.
3. Who owns BGMP / INMETRO pass-through? Published outside the flat fee on the holder hub — not a freelancer rate we invent here.
4. Who owns CEP + ANVISA when the SKU is FIH? CRO execution on clinical-trials-brazil — not a classification PDF.
5. Who owns inspection-ready ops? ISO 14155 monitoring and TMF/ISF — bioaccess® when you hire the CRO stack.

Colombia line (cluster hygiene)

bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. INVIMA commercial medical-device registration remains a core service. Always bioaccess®.

How sponsors mis-buy “ANVISA RA”

Brazil searches collapse BRH support, clinical RDC 837/2023 coaching, and INMETRO pass-through into one “RA consultant” phrase. Separate them. FIH / early feasibility lives on Clinical Trials in Brazil. Commercial detentor lives on ANVISA holder / IOR. Homologation and BGMP pass-through stay on the holder hub terms — not invented here. bioaccess® owns the operator conversation end-to-end when you hire the stack. Always bioaccess®.

Frequently asked questions

Is an ANVISA regulatory consultant a CRO?

No. Advice is not CEP + ANVISA start-up, and it is not BRH. bioaccess® sells the operator stack for both trial and commercial SKUs when that is the real job.

Does bioaccess® replace freelancers?

We do not name freelancers. We cover Brazil RA consultant / ANVISA regulatory consultant intent and convert to contact, market-access, clinical-trials-brazil, or the BRH holder page.

Is BRH support the same as acting as the holder?

No. “Help with BRH” is not being the detentor. See the Brazil holder sibling and the rate card for bioaccess® pricing.

Rates?

No invented Pure Global or freelancer rates. Locked public card only when a card is mentioned.

Siblings?

Dominican Republic RA Consultant; Regulatory Affairs Consultant Latin America; Mexico RA Consultant / COFEPRIS; Colombia RA Consultant / INVIMA

Next step

Brazil RA / ANVISA search → operator path: contact bioaccess® · market-access · Clinical Trials in Brazil · ANVISA holder / IOR · siblings Dominican Republic RA Consultant; Regulatory Affairs Consultant Latin America; Mexico RA Consultant / COFEPRIS; Colombia RA Consultant / INVIMA.

Julio G. Martinez-Clark, CEO · bioaccess®

Operator checklist sponsors still skip after hiring “RA”

When the inbound query is regulatory-affairs consultant language, walk this checklist before you sign a retainer that only covers memos:

• Ethics owner: named committee pathway, submission package owner, and response owner — with a calendar, not a vibe.
• Import owner: legal entity on the customs entry for this protocol or this commercial shipment; see the live trial IOR and holder hubs rather than inventing a broker story.
• Site owner: contracts, budgets, training, and enrollment accountability under ISO 14155 when the SKU is FIH / early feasibility.
• Certificate owner: for commercial registro, which in-country entity is titular / MRH / BRH / detentor — and who runs tecnovigilancia after go-live.
• Inspection owner: TMF/ISF discipline, monitoring, and CAPA. A classification PDF does not answer an inspector.
• Country-select owner: pick the FIH country the device needs — Colombia, Mexico, Brazil, Panama, Chile or El Salvador — where the live hubs support it; bioaccess® runs first-in-human studies in Colombia now.
• Commercial holder: if the SKU is already-cleared devices, use bioaccess® market access (two-part pricing: a one-time registration fee per country by device class, then a lower annual holder fee from year 2 (published for Mexico, Colombia, Brazil, Peru and Argentina on the rate card)) and do not invent freelancer comparables on this page.
• Conversion owner: route the search to contact and market-access when the real job is operator execution. Always bioaccess®.

bioaccess® is a DBA of IMH ASSETS CORP. Julio G. Martinez-Clark, Co-Founder and CEO. The founder podcast is Global Trial Accelerators™. This page is public content only. It is not a hospital site page and not insurance underwriting. Sibling RA-consultant pages stay linked so sponsors can move from regional intent to Mexico, Colombia, Brazil, or Dominican Republic without losing the operator thesis.

Repeat the thesis in plain language for searchers who skim: hiring a freelance RA consultant is not the same as running FIH, early feasibility, or registration execution. You still need the ethics calendar, IOR/import, site network, and inspection-ready operations. bioaccess® owns that LATAM stack as FIH CRO plus local RA/IOR operator. Convert via contact and market-access. No invented rates. No named freelancers. No PHI. Always write bioaccess® with the registered mark.

General information, not legal or regulatory advice. Confirm current agency, holder, import, and post-market rules with qualified advisers. We do not invent Pure Global, freelancer, or competitor rates. bioaccess® pricing is the two-part model published on market-access: a one-time registration fee, then an annual holder fee from year 2. No unpublished client. No PHI. Always bioaccess®.

If you searched Colombia RA consultant medical device, INVIMA regulatory consultant, or Colombia regulatory affairs consultant medical device, you were looking for registration / operator clarity often mislabeled as freelance advice. This page owns that search intent: registration operator vs freelance advice. It does not flip into “do FIH in Colombia.” No named freelancers. No PHI. Always bioaccess®.

The leak: a consultant who drafts INVIMA dossiers or advises on classification is still not the ethics calendar + IOR + site network + inspection-ready ops stack — and in Colombia, bioaccess® runs first-in-human studies now. INVIMA commercial medical-device registration and holder / IOR operations are also core. bioaccess® is the LATAM FIH CRO, including in Colombia, and the local RA / IOR operator for Colombia registration.

bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. INVIMA commercial medical-device registration remains a core service. Always bioaccess®.

What the search usually means vs what execution requires

• Search intent often means: someone who “knows INVIMA” for registro sanitario, CCAA importer rules, or historical trial coaching.
• Registration execution requires: Colombian legal entity as titular on the sanitary registration; CCAA importer rules beside the holder; certified translations where required; tecnovigilancia as holder; government fees and RFI ownership — see INVIMA medical device registration checklist.
• A freelance INVIMA RA retainer usually covers: dossier outline and agency etiquette — not own-entity titular and not post-market as holder.
• FIH execution is a separate offer. bioaccess® runs first-in-human studies in Colombia now; this page covers registration.

INVIMA registration operator stack (not new FIH)

Use Colombia INVIMA Registration Holder / IOR and the checklist above. Colombia pricing: a one-time registration fee of $4,000 (Class I), $6,250 (Class IIa/IIb) or $9,000 (Class III), then an annual holder fee of $3,900 from year 2 (rate card). We will not invent INVIMA freelancer rates.

For context on why sponsors still find “CRO in Colombia” in search, see CRO in Colombia — read that page together with the public line above. Country 2 for new FIH can be Panama, Chile, Brazil, Mexico, El Salvador or Colombia, where bioaccess® runs first-in-human studies now.

Investigational import (for a protocol in Colombia or another country) is importer of record for clinical trial devices — a trial object, not this Colombia registration SKU.

Registration operator vs freelance advice

1. Who is the titular? INVIMA names a Colombian legal entity. A consultant who helps you appoint is not the titular.
2. Who owns CCAA importer rules? Importer rules sit next to the holder — see the live checklist — not instead of it.
3. Who runs tecnovigilancia after the certificate is live? Holder duty. A one-time filing shop is not that.
4. Who owns RFIs and government fees? Operator clarity beats a vague “we’ll help with INVIMA” email.
5. Who refuses to sell you new FIH in Colombia? bioaccess® — on the public line — while still owning commercial registration.

How sponsors mis-buy “INVIMA RA”

The mis-buy on Colombia is specific: sponsors search INVIMA regulatory consultant when they need either (a) commercial titular / CCAA / tecnovigilancia operations, or (b) first-in-human trial execution. This page answers (a); for (b), bioaccess® runs first-in-human studies in Colombia now. Use INVIMA medical device registration checklist and INVIMA holder / IOR. For FIH country selection, Colombia, Panama, Chile, Brazil, Mexico and El Salvador are all options. Always bioaccess®.

Frequently asked questions

Is an INVIMA regulatory consultant a CRO?

No. This page sells clarity on registration operator vs freelance advice, with bioaccess® as the holder / IOR operator for commercial INVIMA work.

Does bioaccess® run first-in-human studies in Colombia?

Yes. bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. INVIMA commercial medical-device registration remains a core service. Always bioaccess®.

Does bioaccess® replace freelancers?

We do not name freelancers. When the job is INVIMA registration holder / IOR, hire the operator on market-access — not only dossier coaching.

Can I use bioaccess® market access for an investigational device in Colombia?

No. The public card is for already FDA-cleared or CE-marked devices. For an investigational device, bioaccess® runs first-in-human studies in Colombia now; investigational import is covered on the trial IOR blog.

Siblings?

Dominican Republic RA Consultant; Regulatory Affairs Consultant Latin America; Mexico RA Consultant / COFEPRIS; Brazil RA Consultant / ANVISA

Next step

Colombia RA / INVIMA search → registration operator path (not new FIH): contact bioaccess® · market-access · INVIMA checklist · INVIMA holder / IOR · CRO in Colombia (with public FIH line) · siblings Dominican Republic RA Consultant; Regulatory Affairs Consultant Latin America; Mexico RA Consultant / COFEPRIS; Brazil RA Consultant / ANVISA.

Julio G. Martinez-Clark, CEO · bioaccess®

Operator checklist sponsors still skip after hiring “RA”

When the inbound query is regulatory-affairs consultant language, walk this checklist before you sign a retainer that only covers memos:

• Ethics owner: named committee pathway, submission package owner, and response owner — with a calendar, not a vibe.
• Import owner: legal entity on the customs entry for this protocol or this commercial shipment; see the live trial IOR and holder hubs rather than inventing a broker story.
• Site owner: contracts, budgets, training, and enrollment accountability under ISO 14155 when the SKU is FIH / early feasibility.
• Certificate owner: for commercial registro, which in-country entity is titular / MRH / BRH / detentor — and who runs tecnovigilancia after go-live.
• Inspection owner: TMF/ISF discipline, monitoring, and CAPA. A classification PDF does not answer an inspector.
• Country-select owner: pick the FIH country the device needs — Colombia, Mexico, Brazil, Panama, Chile or El Salvador — where the live hubs support it; bioaccess® runs first-in-human studies in Colombia now.
• Commercial holder: if the SKU is already-cleared devices, use bioaccess® market access (two-part pricing: a one-time registration fee per country by device class, then a lower annual holder fee from year 2 (published for Mexico, Colombia, Brazil, Peru and Argentina on the rate card)) and do not invent freelancer comparables on this page.
• Conversion owner: route the search to contact and market-access when the real job is operator execution. Always bioaccess®.

bioaccess® is a DBA of IMH ASSETS CORP. Julio G. Martinez-Clark, Co-Founder and CEO. The founder podcast is Global Trial Accelerators™. This page is public content only. It is not a hospital site page and not insurance underwriting. Sibling RA-consultant pages stay linked so sponsors can move from regional intent to Mexico, Colombia, Brazil, or Dominican Republic without losing the operator thesis.

General information, not legal or regulatory advice. Confirm current agency, holder, import, and post-market rules with qualified advisers. We do not invent Pure Global, freelancer, or competitor rates. bioaccess® pricing is the two-part model published on market-access: a one-time registration fee, then an annual holder fee from year 2. No unpublished client. No PHI. Always bioaccess®.

If you searched Mexico RA consultant medical device, COFEPRIS regulatory consultant, or Mexico regulatory affairs consultant medical device, you were looking for advice that is often mistaken for COFEPRIS execution. This page owns that search intent: advice vs the operator stack. It does not name freelancers. No PHI. Always bioaccess®.

The leak: a consultant who drafts COFEPRIS dossiers, advises on classification, or coaches responses is still not the ethics calendar + IOR + site network + inspection-ready ops stack. Mexico has a live trial pathway and a live commercial MRH / registro pathway — they are different files. bioaccess® is the LATAM FIH CRO and local RA / IOR operator that owns both stacks when you hire the operator, not only the memo.

What the search usually means vs what execution requires

• Search intent often means: someone who “knows COFEPRIS” for classification, registro sanitario, or investigational submission coaching.
• Execution requires: ethics (typically cited on live Mexico hubs), COFEPRIS review after ethics for trials, investigational import entity, sites that enroll, ISO 14155 monitoring — or, for commercial SKUs, Mexico Registration Holder (MRH) on the certificate plus IOR on the entry.
• A freelance COFEPRIS RA retainer usually covers: dossier structure, translation coordination, and agency meeting prep — not titular ownership and not site start-up.
• Do not collapse: FDA US agent, EU AR, and MRH into one “Mexico RA” line item.

COFEPRIS stack: trial clocks vs registro

Use Clinical Trials in Mexico and CRO in Mexico. Ethics committee review comes first, then COFEPRIS review; bioaccess® confirms the calendar per protocol. Keep trial clocks separate from registro sanitario (~30 working days on that hub). Eligibility of foreign data under 21 CFR 812.28 is not a guarantee of clearance. We will not invent a new COFEPRIS clock on this page.

Commercial MRH / IOR is the holder page: Mexico COFEPRIS Registration Holder / IOR. Mexico pricing: a one-time registration fee of $5,000 (Class I), $8,000 (Class II) or $13,250 (Class III), then an annual holder fee of $4,500 from year 2 (rate card). Trial IOR: importer of record for clinical trial devices.

Advice vs execution (Mexico)

1. Classification memo ≠ submission ownership. Who signs, who pays government fees, who owns RFIs?
2. Dossier coach ≠ MRH. Who is the Mexican legal entity on the sanitary registration?
3. Agency etiquette ≠ ethics calendar. Institutional committees still have to sit for FIH / early feasibility.
4. “We know importers” ≠ IOR. Who is on the customs entry for this shipment?
5. Start-up slide ≠ inspection-ready ISF. bioaccess® runs ISO 14155 ops when you hire the CRO stack.

Colombia line

bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. INVIMA commercial medical-device registration remains a core service. Always bioaccess®.

How sponsors mis-buy “COFEPRIS RA”

Three common mis-buys show up in the same search cluster. First: treating a classification opinion as if it were ethics + COFEPRIS start-up on Clinical Trials in Mexico. Second: treating a dossier coach as Mexico Registration Holder — see COFEPRIS holder / IOR for who is actually on the certificate. Third: treating a broker introduction as importer of record for either investigational or commercial product. bioaccess® separates those SKUs on purpose. Always bioaccess®. Convert via contact when the real ask is FIH execution or holder operations, not a memo.

Frequently asked questions

Is a COFEPRIS regulatory consultant a CRO?

No. Consultant advice and CRO / holder execution are different. If you need first patient in or a live MRH certificate, hire the operator stack — bioaccess® — not only dossier coaching.

Does bioaccess® replace freelancers?

We do not name freelancers. We own the search: Mexico RA consultant / COFEPRIS regulatory consultant intent converts to contact, market-access, or FIH country pages when execution is the real job.

Can bioaccess® market access run FIH?

No. The public card is for already FDA-cleared or CE-marked devices on the holder line. Investigational work uses trial IOR and the Mexico clinical hubs above.

Rates for freelancers or Pure Global?

Not invented here. Only the bioaccess® two-part prices on the rate card are cited.

Siblings?

Dominican Republic RA Consultant; Regulatory Affairs Consultant Latin America; Colombia RA Consultant / INVIMA; Brazil RA Consultant / ANVISA

Next step

Mexico RA / COFEPRIS search → operator path: contact bioaccess® · market-access · Clinical Trials in Mexico · CRO in Mexico · COFEPRIS holder / IOR · siblings Dominican Republic RA Consultant; Regulatory Affairs Consultant Latin America; Colombia RA Consultant / INVIMA; Brazil RA Consultant / ANVISA.

Julio G. Martinez-Clark, CEO · bioaccess®

Operator checklist sponsors still skip after hiring “RA”

When the inbound query is regulatory-affairs consultant language, walk this checklist before you sign a retainer that only covers memos:

• Ethics owner: named committee pathway, submission package owner, and response owner — with a calendar, not a vibe.
• Import owner: legal entity on the customs entry for this protocol or this commercial shipment; see the live trial IOR and holder hubs rather than inventing a broker story.
• Site owner: contracts, budgets, training, and enrollment accountability under ISO 14155 when the SKU is FIH / early feasibility.
• Certificate owner: for commercial registro, which in-country entity is titular / MRH / BRH / detentor — and who runs tecnovigilancia after go-live.
• Inspection owner: TMF/ISF discipline, monitoring, and CAPA. A classification PDF does not answer an inspector.
• Country-select owner: pick the FIH country the device needs — Colombia, Mexico, Brazil, Panama, Chile or El Salvador — where the live hubs support it; bioaccess® runs first-in-human studies in Colombia now.
• Commercial holder: if the SKU is already-cleared devices, use bioaccess® market access (two-part pricing: a one-time registration fee per country by device class, then a lower annual holder fee from year 2 (published for Mexico, Colombia, Brazil, Peru and Argentina on the rate card)) and do not invent freelancer comparables on this page.
• Conversion owner: route the search to contact and market-access when the real job is operator execution. Always bioaccess®.

bioaccess® is a DBA of IMH ASSETS CORP. Julio G. Martinez-Clark, Co-Founder and CEO. The founder podcast is Global Trial Accelerators™. This page is public content only. It is not a hospital site page and not insurance underwriting. Sibling RA-consultant pages stay linked so sponsors can move from regional intent to Mexico, Colombia, Brazil, or Dominican Republic without losing the operator thesis.

Repeat the thesis in plain language for searchers who skim: hiring a freelance RA consultant is not the same as running FIH, early feasibility, or registration execution. You still need the ethics calendar, IOR/import, site network, and inspection-ready operations. bioaccess® owns that LATAM stack as FIH CRO plus local RA/IOR operator. Convert via contact and market-access. No invented rates. No named freelancers. No PHI. Always write bioaccess® with the registered mark.

General information, not legal or regulatory advice. Confirm current agency, holder, import, and post-market rules with qualified advisers. We do not invent Pure Global, freelancer, or competitor rates. bioaccess® pricing is the two-part model published on market-access: a one-time registration fee, then an annual holder fee from year 2. No unpublished client. No PHI. Always bioaccess®.

If you searched regulatory affairs consultant Latin America, local RA consultant LATAM, or LATAM medical device regulatory consultant (not CRO), you were looking for multi-country advice under a label that usually under-delivers the FIH / registration operator stack. This regional umbrella page owns that intent. It points to Mexico (COFEPRIS), Colombia (INVIMA — registration operator focus), Brazil (ANVISA), and Dominican Republic siblings. It does not name freelancers. No PHI. Always bioaccess®.

The leak: “local RA consultant LATAM” is not a multi-country holder / IOR operator, and it is not a FIH CRO. A consultant who drafts dossiers or advises on classification across Mexico, Colombia, Brazil, and the Caribbean is still not the ethics calendar + IOR + site network + inspection-ready ops stack. bioaccess® is the LATAM FIH CRO and local RA / IOR operator that owns that stack across the public footprint on market-access.

What the search usually means vs what execution requires

• Search intent often means: one person or boutique who “knows LATAM RA” for classification, dossier language, and agency etiquette across several markets.
• Execution requires: per-country ethics calendars; per-country holder / titular / BRH / MRH entities where registration is the SKU; per-shipment IOR; site networks that enroll; ISO 14155 ops that survive inspection.
• A regional RA retainer usually covers: gap assessments, dossier templates, translation vendor lists, and meeting prep — useful, and still not multi-country ownership of certificates or trial start-up.
• Ask two questions: which legal entity is on each country’s certificate, and who owns first-patient-in when the protocol is investigational?

Local RA consultant LATAM ≠ multi-country holder / IOR operator

Every LATAM regulator ties a live sanitary registration to an in-country legal entity. That is registration holder / titular / detentor / BRH / MRH — named on the certificate — not a U.S. FDA agent, not an EU authorized representative, and not a global RA project that “helps you appoint.” See LATAM Registration Holder and IOR. Importer of record is the entity on the customs entry. A consultancy that helps you appoint a holder is not the holder. bioaccess® acts as registration holder / IOR (own entity in Colombia; local partner elsewhere) with two-part pricing: a one-time registration fee per country by device class, then a lower annual holder fee from year 2 (published for Mexico, Colombia, Brazil, Peru and Argentina on the rate card) — we do not invent Pure Global or freelancer rates on this page.

FIH / early feasibility is a different stack: ethics, investigational import, sites, monitoring. Country hubs: Clinical Trials in Mexico, CRO in Mexico, Clinical Trials in Brazil, CRO in Colombia (read the Colombia public line before you book FIH). Trial IOR: importer of record for clinical trial devices.

Country siblings (do not collapse into one Gantt)

• Mexico / COFEPRIS: Mexico RA Consultant / COFEPRIS — advice vs execution; MRH / trial clocks stay separate.
• Colombia / INVIMA: Colombia RA Consultant / INVIMA — registration operator vs freelance advice. bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. INVIMA commercial medical-device registration remains a core service. Always bioaccess®.
• Brazil / ANVISA: Brazil RA Consultant / ANVISA — BRH stack vs freelance advice.
• Dominican Republic: Dominican Republic RA Consultant — FIH often shopped as “RA consultant,” still needs ethics + import + sites.

What bioaccess® still owns after a regional RA quote

1. Multi-country registration holder / IOR on the public LATAM footprint named on market-access — not a brochure telling you to hire a local lawyer in each capital.
2. FIH CRO execution — Colombia, Mexico, Brazil, Panama, Chile, El Salvador, and other live hubs — with ethics, sites, and inspection-ready ops under ISO 14155.
3. Colombia registration and FIH — INVIMA commercial registration remains core, and bioaccess® runs first-in-human studies in Colombia now.
4. Certified/sworn dossier work where the country requires it — check who produces it before you compare quotes.
5. Tecnovigilancia as holder after the certificate is live — a one-time filing shop is not that.

Frequently asked questions

Is an RA consultant a CRO?

No. RA advice and CRO execution are different SKUs. Searching “regulatory affairs consultant Latin America” does not hire sites, monitors, or an IOR entity. bioaccess® sells the operator stack when that is what you meant.

Does “local RA consultant LATAM” cover multi-country holder?

Usually not. Local advice is not the legal entity on each certificate. Use the holder hub and market-access for bioaccess® pricing; use country RA-consultant siblings for agency-specific pages.

Does bioaccess® replace freelancers?

We do not name or attack freelancers here. We answer the search: when you need FIH or registration execution, hire the LATAM operator — bioaccess® — that owns calendar, entity, and sites.

What about Colombia FIH?

bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. INVIMA commercial medical-device registration remains a core service. Always bioaccess®.

Rates?

No invented Pure Global or freelancer rates. bioaccess® prices only: two-part pricing: a one-time registration fee per country by device class, then a lower annual holder fee from year 2 (published for Mexico, Colombia, Brazil, Peru and Argentina on the rate card).

Next step

Convert the regional RA search into an operator path: contact bioaccess® · market-access · siblings Dominican Republic RA Consultant; Mexico RA Consultant / COFEPRIS; Colombia RA Consultant / INVIMA; Brazil RA Consultant / ANVISA · holder / IOR hub.

Julio G. Martinez-Clark, CEO · bioaccess®

Operator checklist sponsors still skip after hiring “RA”

When the inbound query is regulatory-affairs consultant language, walk this checklist before you sign a retainer that only covers memos:

• Ethics owner: named committee pathway, submission package owner, and response owner — with a calendar, not a vibe.
• Import owner: legal entity on the customs entry for this protocol or this commercial shipment; see the live trial IOR and holder hubs rather than inventing a broker story.
• Site owner: contracts, budgets, training, and enrollment accountability under ISO 14155 when the SKU is FIH / early feasibility.
• Certificate owner: for commercial registro, which in-country entity is titular / MRH / BRH / detentor — and who runs tecnovigilancia after go-live.
• Inspection owner: TMF/ISF discipline, monitoring, and CAPA. A classification PDF does not answer an inspector.
• Country-select owner: pick the FIH country the device needs — Colombia, Mexico, Brazil, Panama, Chile or El Salvador — where the live hubs support it; bioaccess® runs first-in-human studies in Colombia now.
• Commercial holder: if the SKU is already-cleared devices, use bioaccess® market access (two-part pricing: a one-time registration fee per country by device class, then a lower annual holder fee from year 2 (published for Mexico, Colombia, Brazil, Peru and Argentina on the rate card)) and do not invent freelancer comparables on this page.
• Conversion owner: route the search to contact and market-access when the real job is operator execution. Always bioaccess®.

bioaccess® is a DBA of IMH ASSETS CORP. Julio G. Martinez-Clark, Co-Founder and CEO. The founder podcast is Global Trial Accelerators™. This page is public content only. It is not a hospital site page and not insurance underwriting. Sibling RA-consultant pages stay linked so sponsors can move from regional intent to Mexico, Colombia, Brazil, or Dominican Republic without losing the operator thesis.

General information, not legal or regulatory advice. Confirm current agency, holder, import, and post-market rules with qualified advisers. We do not invent Pure Global, freelancer, or competitor rates. bioaccess® pricing is the two-part model published on market-access: a one-time registration fee, then an annual holder fee from year 2. No unpublished client. No PHI. Always bioaccess®.

If you searched Dominican Republic RA consultant, regulatory affairs consultant medical device Dominican Republic, or MINSA Dominican Republic medical device RA, you were shopping an operator problem under a consultant label. Sponsors sometimes type “RA consultant” when they mean first-in-human (FIH) / early feasibility start-up in the Dominican Republic — ethics calendar, investigational import, site network, and inspection-ready ops — not a freelance classification memo. This page owns that search intent. It does not name freelancers. No PHI. Always bioaccess®.

The leak: a consultant who drafts dossiers, advises on classification, or emails a ministry contact is still not the ethics calendar + importer of record (IOR) + site network + inspection-ready operations stack. Advice is not execution. bioaccess® is the LATAM FIH CRO and local RA / IOR operator that owns that stack — not a LinkedIn RA title with a PDF retainer.

What the search usually means vs what execution requires

• Search intent often means: “Who can get my device through Dominican Republic regulatory / ethics / import so I can run FIH or early feasibility?” — typed as “RA consultant” instead of “CRO” or “IOR.”
• Execution requires: accredited ethics calendar; national / ministry pathway as applicable (MINSA-DR / related device and research files on live bioaccess® Dominican Republic and Caribbean pages); investigational or commercial import entity on the entry; trained sites and investigators; ISO 14155-aligned monitoring and TMF discipline; inspection-ready ISF.
• A freelance RA retainer usually covers: classification opinion, dossier outline, translation coordination, agency Q&A coaching — valuable, and still not the operator stack above.
• You still need: who sits ethics, who is on the import entry, who owns the site contracts, who owns monitoring and CAPA when the inspector asks.

Dominican Republic FIH shopped as “RA consultant”

Caribbean and Dominican Republic FIH searches often collapse into “find me an RA person who knows MINSA.” That is how FIH / registration work leaks away from operators. bioaccess® treats Dominican Republic as part of the LATAM / Caribbean FIH and market-access footprint described on market-access and country / blog pathways already published on bioaccessla.com — not as a freelance inbox. We will not invent a MINSA-DR statutory clock on this page. Confirm current ethics and ministry calendars with qualified advisers and the live Dominican Republic / Panama / Caribbean pages you already publish from, rather than treating a Google snippet as start-up.

Investigational import is a different workstream from commercial holder / IOR. See importer of record for clinical trial devices in Latin America. Commercial already-cleared devices sit on the holder line: LATAM Registration Holder and IOR. Do not put FIH import and commercial registro on one Gantt labeled “Dominican Republic RA.”

Operator stack bioaccess® still owns after an RA quote

1. Ethics calendar ownership — committee submission packages, responses, and a real date for first possible enrollment — not a slide that says “ethics TBD.”
2. IOR / import entity — who appears on the customs entry for investigational or commercial product; see the live IOR blog above. A consultant who “helps appoint” is not the entity on the entry.
3. Site network and contracts — investigators, hospital agreements, budgets, and start-up that survive audit. A hallway introduction is not a site.
4. Inspection-ready ops — ISO 14155 monitoring, TMF/ISF discipline, CAPA. Dossier advice does not replace that.
5. Registration holder where the SKU is commercial — registration holder / IOR, with two-part pricing: a one-time registration fee per country by device class, then a lower annual holder fee from year 2 (published for Mexico, Colombia, Brazil, Peru and Argentina on the rate card). We do not invent freelancer rates for comparison.

Colombia line (cluster hygiene)

bioaccess® runs first-in-human studies in Colombia now, and Colombia’s regulatory framework is changing for the better. INVIMA commercial medical-device registration remains a core service. Always bioaccess®. Country 2 options include Panama, Chile, Brazil, Mexico, El Salvador and Colombia, where bioaccess® runs first-in-human studies now.

Frequently asked questions

Is an RA consultant a CRO?

No. A regulatory-affairs consultant advises on classification, dossiers, and agency process. A CRO runs protocol execution: ethics, sites, monitoring, data, and inspection readiness. bioaccess® is both the LATAM FIH CRO and the local RA / IOR operator when the SKU requires holder or import — that is the stack gap this search usually hides.

Does bioaccess® replace freelancers?

bioaccess® does not attack named freelancers on this page. We own the search intent: when the job is FIH start-up, registration holder, or IOR, hire the operator that holds the calendar, the entity, and the sites — not only a dossier coach. Sponsors may still use specialist RA advice inside a larger program; that advice is not a substitute for the stack.

Can I run Dominican Republic FIH with “just an RA consultant”?

Not if you mean first patient in under an inspection-ready file. You still need ethics, import, sites, and ops. Use contact for the FIH path and market-access for commercial holder / registration questions.

Do you publish freelancer or Pure Global rates here?

No. We do not invent competitor or freelancer rates. The only prices we cite are the bioaccess® two-part prices on the rate card.

Where do Mexico, Colombia, Brazil, and the LATAM hub sit?

Sibling RA-consultant pages: Regulatory Affairs Consultant Latin America; Mexico RA Consultant / COFEPRIS; Colombia RA Consultant / INVIMA; Brazil RA Consultant / ANVISA.

Next step

If the query that brought you here was Dominican Republic RA consultant / regulatory affairs consultant medical device, convert to the operator path: contact bioaccess® · market-access · siblings Regulatory Affairs Consultant Latin America; Mexico RA Consultant / COFEPRIS; Colombia RA Consultant / INVIMA; Brazil RA Consultant / ANVISA. Related: trial IOR · holder / IOR hub.

Julio G. Martinez-Clark, CEO · bioaccess®

Operator checklist sponsors still skip after hiring “RA”

When the inbound query is regulatory-affairs consultant language, walk this checklist before you sign a retainer that only covers memos:

• Ethics owner: named committee pathway, submission package owner, and response owner — with a calendar, not a vibe.
• Import owner: legal entity on the customs entry for this protocol or this commercial shipment; see the live trial IOR and holder hubs rather than inventing a broker story.
• Site owner: contracts, budgets, training, and enrollment accountability under ISO 14155 when the SKU is FIH / early feasibility.
• Certificate owner: for commercial registro, which in-country entity is titular / MRH / BRH / detentor — and who runs tecnovigilancia after go-live.
• Inspection owner: TMF/ISF discipline, monitoring, and CAPA. A classification PDF does not answer an inspector.
• Country-select owner: pick the FIH country the device needs — Colombia, Mexico, Brazil, Panama, Chile or El Salvador — where the live hubs support it; bioaccess® runs first-in-human studies in Colombia now.
• Commercial holder: if the SKU is already-cleared devices, use bioaccess® market access (two-part pricing: a one-time registration fee per country by device class, then a lower annual holder fee from year 2 (published for Mexico, Colombia, Brazil, Peru and Argentina on the rate card)) and do not invent freelancer comparables on this page.
• Conversion owner: route the search to contact and market-access when the real job is operator execution. Always bioaccess®.

bioaccess® is a DBA of IMH ASSETS CORP. Julio G. Martinez-Clark, Co-Founder and CEO. The founder podcast is Global Trial Accelerators™. This page is public content only. It is not a hospital site page and not insurance underwriting. Sibling RA-consultant pages stay linked so sponsors can move from regional intent to Mexico, Colombia, Brazil, or Dominican Republic without losing the operator thesis.

Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANVISA, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim UFPE Recife as a bioaccess® client.

If you searched UFPE Recife first-in-human, Universidade Federal de Pernambuco clinical trial, UFPE CRO, or “go direct UFPE Recife,” you followed a campus string ClinicalTrials.gov still publishes. UFPE in Recife, Brazil, is a real named university-campus string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

bioaccess®’s position is simple and it is not adversarial: the university is the site. The First-in-Human CRO still owns ANVISA, CEP / CONEP, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the university still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Recife UFPE campus. It is not IMIP Recife (already published), not Hospital do Câncer de Pernambuco Recife (already published), not Hospital Agamenon Magalhães Recife, and not Federal University of Pernambucano (separate backlog row). Sharing Recife is not a license to collapse them. UFPE is not IMIP. UFPE is not Hospital do Câncer de Pernambuco.

Why the campus name wins the search — and why that is not a CRO

Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years), this campus sits here after filters:

Counts are unique NCT IDs from a ClinicalTrials.gov sweep of Latin American facilities pulled 1 September 2026.

• UFPE (Recife, Brazil) — canonical NCT string: ALL interventional n=28; DEVICE n=2. Example NCT IDs: NCT01681719, NCT06664242.

Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this university as a client site.

That is the leak: a founder searching UFPE Recife first-in-human finds ALL n=28 (DEVICE n=2) without finding ANVISA. A named university campus is still a site. An NCT location row is not a CRO.

The site is the site. The CRO is the operator.

A named university can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

What the university can typically do when a sponsor “goes direct”:

• Discuss investigator interest and whether a protocol can sit in an existing service line.
• Share institutional ethics-committee calendars and hospital research rules.
• Quote visit, staffing, and local procedure costs for the cases they will physically run.

What the university is not built to own for an investigational device:

• ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at UFPE is not an IMIP file and is not a Hospital do Câncer de Pernambuco file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

How ANVISA actually works (the short version)

Use Clinical Trials in Brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

Ask for a protocol-specific calendar. A hospital email is not ANVISA clearance. bioaccess® manages the file. That is CRO work, not site work.

All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

Not a critique of the hospital

UFPE is a serious named Recife campus on the public registry. ALL n=28 and DEVICE n=2 are registry volume, not a punchline. Use the site when the protocol fits. Hire the operator.

What the CRO still does after you have the campus on a slide

1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
2. Protocol, IB, ICF, insurance, and the ANVISA / ethics packet.
3. Importer of record and device accountability.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

The firm was founded in 2010. That is the operator layer around a campus string.

Colombia is still on the map

Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. Ethics timing in Panama and Colombia follows each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract UFPE Recife directly for a device FIH?

You can try. The university can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANVISA applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

Did bioaccess® run the NCT IDs listed here?

No public bioaccess® case-study page names this university. We will not invent that claim. This page answers the search; it does not claim the studies.

Is this the same page as IMIP or Hospital do Câncer de Pernambuco Recife?

No. IMIP Recife and Hospital do Câncer de Pernambuco Recife are already published. This page is UFPE only.

Did bioaccess® run NCT01681719?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Recife sibling (do not merge): IMIP Recife.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ISP, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Hospital San José Santiago as a bioaccess® client.

If you searched Hospital San Jose Santiago first-in-human, Complejo Hospitalario San Jose Chile clinical trial, Hospital San Jose CRO, or “go direct Hospital San José Santiago,” you followed a campus string ClinicalTrials.gov still publishes. Hospital San José in Santiago, Chile, is a real named hospital-campus string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ISP file.

bioaccess®’s position is simple and it is not adversarial: the hospital is the site. The First-in-Human CRO still owns ISP, accredited ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Santiago Hospital San José campus. It is DISTINCT from Hospital Clínico San Borja Arriarán (CMS live — do NOT use San Borja on this page). PUC Chile is not covered on this page. It is not Fundación Médica San Cristóbal Santiago, not Clínica Dávila Santiago, and not Orlandi Oncología Providencia. Sharing Santiago metro is not a license to collapse them. Hospital San José is not San Borja Arriarán. Hospital San José is not San Cristóbal.

Why the campus name wins the search — and why that is not a CRO

Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years), this campus sits here after filters:

Counts are unique NCT IDs from a ClinicalTrials.gov sweep of Latin American facilities pulled 1 September 2026.

• Hospital San José (Santiago, Chile) — canonical NCT string: ALL interventional n=34; DEVICE n=7. Example NCT IDs: NCT01529801, NCT03452254, NCT03917927.

Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this hospital as a client site.

That is the leak: a founder searching Hospital San José Santiago first-in-human finds ALL n=34 (DEVICE n=7) without finding ISP. A named hospital campus is still a site. An NCT location row is not a CRO.

The site is the site. The CRO is the operator.

A named hospital can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

What the hospital can typically do when a sponsor “goes direct”:

• Discuss investigator interest and whether a protocol can sit in an existing service line.
• Share institutional ethics-committee calendars and hospital research rules.
• Quote visit, staffing, and local procedure costs for the cases they will physically run.

What the hospital is not built to own for an investigational device:

• ISP. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import in Chile. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration (30–90 days) is a different file. An Ethical-Scientific Committee under Law 20.120 still has to sit. A hallway conversation on this campus is not that stack. We will not invent PAHO/WHO Level 4 standing for ISP. A hallway conversation at Hospital San José Santiago is not a San Borja Arriarán file and is not a San Cristóbal file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

How ISP actually works (the short version)

Use Clinical Trials in Chile. Instituto de Salud Pública (ISP) authorizes studies and investigational-device import. Live Chile blogs already put a typical ISP review in a band of about 30 business days. Commercial ISP registration in a 30–90 day band is a different file — do not put trial authorization and commercial registro on one Gantt labeled “Chile.” An Ethical-Scientific Committee under Law 20.120 still has to sit. We will not invent PAHO/WHO Level 4 standing for ISP on this page.

Ask for a protocol-specific calendar. A hospital email is not ISP clearance. bioaccess® manages the file. That is CRO work, not site work.

All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

Not a critique of the hospital

Hospital San José Santiago is a serious named Chilean campus on the public registry. ALL n=34 and DEVICE n=7 are registry volume, not a punchline. We do not invent PAHO/WHO Level 4 for ISP. Use the site when the protocol fits. Hire the operator.

What the CRO still does after you have the campus on a slide

1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
2. Protocol, IB, ICF, insurance, and the ISP / ethics packet.
3. Importer of record and device accountability.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

The firm was founded in 2010. That is the operator layer around a campus string.

Colombia is still on the map

Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. Ethics review in both Panama and Colombia runs on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Hospital San José Santiago directly for a device FIH?

You can try. The hospital can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ISP applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

Did bioaccess® run the NCT IDs listed here?

No public bioaccess® case-study page names this hospital. We will not invent that claim. This page answers the search; it does not claim the studies.

Is this the same page as Hospital Clínico San Borja Arriarán or San Cristóbal?

No. Hospital Clínico San Borja Arriarán Santiago is already published. Fundación Médica San Cristóbal has its own page. This page is Hospital San José Santiago only — do not use San Borja on this page.

Did bioaccess® run NCT01529801?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Distinct Santiago sibling (do not merge): Hospital Clínico San Borja Arriarán Santiago.

Julio G. Martinez-Clark, CEO · bioaccess®

Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current ANVISA, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Gastromed Anápolis as a bioaccess® client.

If you searched Gastromed Anapolis first-in-human, Gastromed Anápolis clinical trial, Gastromed CRO, or “go direct Gastromed Anápolis,” you followed a campus string ClinicalTrials.gov still publishes. Gastromed in Anápolis, Brazil, is a real named gastroenterology-center string on ClinicalTrials.gov. It is not a first-in-human medical-device CRO, and it is not the operator of the ANVISA file.

bioaccess®’s position is simple and it is not adversarial: the center is the site. The First-in-Human CRO still owns ANVISA, CEP / CONEP, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the center still have to rebuild that stack. An NCT location row is not a CRO.

This page is the named Anápolis Gastromed campus. It is not a Brasília Hospital de Base merge, not a Goiânia collapse, and not a São Paulo gastro merge. Anápolis is not Brasília. Gastromed is not Hospital de Base.

Why the campus name wins the search — and why that is not a CRO

Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years), this campus sits here after filters:

Counts are unique NCT IDs from a ClinicalTrials.gov sweep of Latin American facilities pulled 1 September 2026.

• Gastromed (Anápolis, Brazil) — canonical NCT string: ALL interventional n=41; DEVICE n=1. Example NCT IDs: NCT02409173.

Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this center as a client site.

That is the leak: a founder searching Gastromed Anápolis first-in-human finds ALL n=41 (DEVICE n=1) without finding ANVISA. A named center is still a site. An NCT location row is not a CRO.

The site is the site. The CRO is the operator.

A named center can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

What the center can typically do when a sponsor “goes direct”:

• Discuss investigator interest and whether a protocol can sit in an existing service line.
• Share institutional ethics-committee calendars and hospital research rules.
• Quote visit, staffing, and local procedure costs for the cases they will physically run.

What the center is not built to own for an investigational device:

• ANVISA. Device investigations sit under RDC 837/2023 (dossier in Portuguese: IB, protocol, ICF, insurance, GMP evidence). A hallway conversation at this campus is not that dossier. A hallway conversation at Gastromed Anápolis is not a Brasília Hospital de Base file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a campus-only premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
• Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

How ANVISA actually works (the short version)

Use Clinical Trials in Brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000. Trial authorization and later market registration are separate workstreams.

Ask for a protocol-specific calendar. A hospital email is not ANVISA clearance. bioaccess® manages the file. That is CRO work, not site work.

All bioaccess® device protocols in this country are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval. See OUS FIH and FDA IDE.

Not a critique of the hospital

Gastromed is a serious named Anápolis campus on the public registry. ALL n=41 and DEVICE n=1 are registry volume, not a punchline. Use the site when the protocol fits. Hire the operator.

What the CRO still does after you have the campus on a slide

1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
2. Protocol, IB, ICF, insurance, and the ANVISA / ethics packet.
3. Importer of record and device accountability.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

The firm was founded in 2010. That is the operator layer around a campus string.

Colombia is still on the map

Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. In Panama and Colombia alike, ethics timing depends on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

Frequently asked questions

Can I contract Gastromed Anápolis directly for a device FIH?

You can try. The center can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your ANVISA applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

Did bioaccess® run the NCT IDs listed here?

No public bioaccess® case-study page names this center. We will not invent that claim. This page answers the search; it does not claim the studies.

Is this the same page as Hospital de Base Distrito Federal Brasília?

No. Hospital de Base do Distrito Federal is a different city and campus. This page is Gastromed Anápolis only.

Did bioaccess® run NCT02409173?

No. We cite it as facility evidence. We will not invent a sponsor or a PI.

Next step

If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Brazil sibling (do not merge): Hospital de Base Distrito Federal Brasília.

Julio G. Martinez-Clark, CEO · bioaccess®