Author: Julio Martinez-Clark

  • Infinite Clinical Research Mexico vs a First-in-Human Device CRO (bioaccess®)

    If you typed Infinite Clinical Research (WEAREINFINITE) into a search box, you are probably building a CRO shortlist. This article uses only what Infinite Clinical Research (WEAREINFINITE) publishes (weareinfinite.mx) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

    What Infinite Clinical Research (WEAREINFINITE) publishes

    Infinite Clinical Research (WEAREINFINITE) is a Mexico City CRO that calls itself "100% Mexican" and full-service, and is a founding member of ACROM. It publishes a research protocols and medical devices service, COFEPRIS device registrations and technovigilance. We found no named device protocol or sponsor on its site.

    Infinite Clinical Research (WEAREINFINITE) vs bioaccess®

    Dimension Infinite Clinical Research (WEAREINFINITE) bioaccess®
    Core focus Mexico full-service CRO with device protocols and COFEPRIS First-in-human and early feasibility studies for medical devices
    Geography Mexico City HQ; lists operations in Mexico, Argentina, Chile, Colombia, Costa Rica, Guatemala, Panama, Dominican Republic and El Salvador, among others Latin America, since 2010
    Device FIH track record No named device first-in-human study found on the public pages reviewed Published case studies on bioaccessla.com
    After the trial COFEPRIS sanitary registration for medicines and devices, import logistics, pharmacovigilance and technovigilance Live multi-country sanitary registration and in-country holder service

    Where each one fits

    If Mexico is the only country and you want one local firm for the protocol and the COFEPRIS registration, Infinite publishes both.

    If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including Infinite Clinical Research (WEAREINFINITE), for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

    Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

    Ready to compare a proposal? Request a first-in-human study proposal.

    Competitor facts from the Infinite Clinical Research (WEAREINFINITE) public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.

  • MSC MED Brazil Device CRO vs a First-in-Human CRO for Latin America (bioaccess®)

    If you typed MSC MED into a search box, you are probably building a CRO shortlist. This article uses only what MSC MED publishes (www.mscmed.com.br/en) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

    What MSC MED publishes

    MSC MED (MSc Med Engenharia e Tecnologia Médica Ltda.) is a Brazilian CRO headquartered in Florianópolis with a commercial office in Curitiba. It describes itself as a CRO specializing in safety and efficacy demonstration and international regulation of medical devices. Services include clinical evaluation (ISO / ANVISA), biocompatibility, MRI compatibility and registration hosting. Heitor Korndorfer is founder and CEO.

    MSC MED vs bioaccess®

    Dimension MSC MED bioaccess®
    Core focus Device clinical evaluation, testing and Brazil regulatory First-in-human and early feasibility studies for medical devices
    Geography Brazil (Florianópolis HQ, Curitiba office); says it has served companies from over 15 countries Latin America, since 2010
    Device FIH track record No named device first-in-human study found on the public pages reviewed Published case studies on bioaccessla.com
    After the trial Brazil registration hosting and ANVISA / FDA regulatory support Live multi-country sanitary registration and in-country holder service

    Where each one fits

    If the job is clinical evaluation, biocompatibility or MRI-compatibility work, or a Brazil registration, MSC MED is built for it.

    If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including MSC MED, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

    Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

    Ready to compare a proposal? Request a first-in-human study proposal.

    Competitor facts from the MSC MED public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.

  • Zenter Research Argentina vs a First-in-Human Device CRO (bioaccess®)

    If you typed Zenter Research into a search box, you are probably building a CRO shortlist. This article uses only what Zenter Research publishes (zenterresearch.com) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

    What Zenter Research publishes

    Zenter Research S.A. is an Argentine CRO in the San Isidro / Buenos Aires area, founded by Victor Molina Viamonte, MD FACC, its CEO and CSO. Its public materials describe cardiovascular "Pharmaceutical & Devices" work, clinical and medical monitoring of pharmaceutical and device trials, and "First Time in Man" Phase I studies, with FDA audits it cites in 2014 and 2019. The device work it describes is cardiovascular Phase II–III megatrials, not a named early feasibility study.

    Zenter Research vs bioaccess®

    Dimension Zenter Research bioaccess®
    Core focus Drug-primary cardiovascular CRO with device monitoring and Phase I First-in-human and early feasibility studies for medical devices
    Geography Argentina; offers legal representation before ANMAT for sponsors outside Argentina Latin America, since 2010
    Device FIH track record No named device first-in-human study found on the public pages reviewed Published case studies on bioaccessla.com
    After the trial See provider site Live multi-country sanitary registration and in-country holder service

    Where each one fits

    If the program is a cardiovascular drug or a large Phase II–III device trial centered in Argentina, Zenter is a credible local option.

    If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including Zenter Research, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

    Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

    Ready to compare a proposal? Request a first-in-human study proposal.

    Competitor facts from the Zenter Research public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.

  • Aruna Asesores LATAM Device Registration vs bioaccess® Registration Holder

    Aruna Asesores shows up when manufacturers search for a Latin American registration holder or sanitary-registration partner. This article uses only what Aruna Asesores publishes on its own site (arunasesores.com/chile-dispositivos-medicos · arunasesores.com/mexico-holder-y-o-representante-legal · arunasesores.com/peru-holder-y-o-titular-para-registro-sanitario), then compares it with the multi-country subscription from bioaccess®. It is a practitioner comparison, not a teardown.

    What Aruna Asesores publishes

    Aruna Asesores is a regulatory firm with country managers in Colombia and Mexico and contact points in Bogotá, Mexico City and Lima. Besides device dossier work, such as its Chile ISP medical devices page, it now publishes holder pages. In Mexico it offers to act as holder or titular of the registration for medicines and medical devices, with a Mexico-qualified responsible technician, technovigilance and pharmacovigilance, the sanitary notice and the establishment license. In Peru it offers holder or titular services and local representation for foreign manufacturers and distributors, and explains that a Peruvian holder needs a droguería license, a BPA-certified warehouse and a pharmacist as technical director.

    Aruna Asesores vs bioaccess®

    Dimension Aruna Asesores bioaccess®
    Public product Holder / titular in Mexico and Peru + multi-country device dossiers (e.g. Chile ISP) LATAM Launch Subscription: registration, in-country holder, certified translations, government fees, tecnovigilancia (import shipments quoted separately)
    Geography Mexico and Peru holder pages; Chile dossier page; Colombia base 19 LATAM markets
    Public pricing None published USD 7,500 per year per country for the first device family
    Holder vs distributor Offers to be the holder or titular in Mexico and Peru, as local representative of foreign manufacturers or distributors Holds through its own in-country entities, with defined transfer provisions; the registration is never leverage
    Bridge from a clinical trial None published Trial-to-Market Bridge: 20% off for bioaccess® clinical-trial clients

    Where each one fits

    If Mexico or Peru is the market and you want a regional regulatory firm to act as holder there, Aruna now publishes that service.

    The LATAM Launch Subscription from bioaccess® is a different product. bioaccess® registers already FDA-cleared or CE-marked devices and holds them through its own in-country entities across 19 Latin American markets, including COFEPRIS, ANVISA, INVIMA, ANMAT, ISP and DIGEMID. The published card is USD 7,500 per year per country for the first device family, with government submission fees, certified or sworn translations, the in-country titular or holder, and tecnovigilancia inside the fee (importer-of-record shipments are priced separately on the hub). Multi-country discounts are 10% at three or more countries and 15% at five or more. The registration is held for the manufacturer’s benefit, with defined transfer provisions if you ever change partners or set up your own entity.

    One country and one local partner is enough? Hire the firm that publishes that job. Several LATAM labels under one holder who is not your distributor? Start at bioaccess® market access, read the LATAM importer of record guide, try the LATAM Launch Calculator, or request a registration quote.

    Competitor facts from the Aruna Asesores public pages linked above, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented clients, prices or contacts.

  • MacroBridge Registro Sanitario DIGEMAPS vs bioaccess® LATAM Registration Holder

    MacroBridge shows up when manufacturers search for a Latin American registration holder or sanitary-registration partner. This article uses only what MacroBridge publishes on its own site (macro-bridge.com/servicios/registro-sanitario), then compares it with multi-country market access from bioaccess®. It is a practitioner comparison, not a teardown.

    What MacroBridge publishes

    MacroBridge is a Dominican Republic firm whose registro sanitario page covers DIGEMAPS dossiers for many product classes, including medical devices and health equipment. It does not describe itself as a third-party holder.

    MacroBridge vs bioaccess®

    Dimension MacroBridge bioaccess®
    Public product DIGEMAPS dossier across product classes Registration, in-country holder, certified translations, tecnovigilancia as holder (import shipments quoted separately)
    Geography Dominican Republic Published pricing in Mexico, Colombia, Brazil, Peru and Argentina; other markets quoted case by case
    Public pricing None published Two-part: one-time registration fee per country by class, then an annual holder fee from year 2 (rate card)
    Holder vs distributor See the provider’s own terms Holder under contract (own Colombian entity in Colombia; local partner elsewhere), with defined transfer provisions; the registration is never leverage
    Bridge from a clinical trial None published Same firm can run the LATAM clinical trial and then hold the commercial registration

    Where each one fits

    If your Dominican distributor will be the holder and you only need DIGEMAPS paperwork, MacroBridge fits.

    bioaccess® market access is a different product. bioaccess® registers already FDA-cleared or CE-marked devices and acts as their registration holder under contract (in Colombia through its own Colombian entity; elsewhere with its local partner) across Latin American markets, including COFEPRIS, ANVISA, INVIMA, ANMAT, ISP and DIGEMID. Pricing is 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). Importer-of-record shipments are quoted separately. The registration is held for the manufacturer’s benefit, with defined transfer provisions if you ever change partners or set up your own entity.

    One country and one local partner is enough? Hire the firm that publishes that job. Several LATAM labels under one holder who is not your distributor? Start at bioaccess® market access, read the LATAM importer of record guide, try the market-access calculator, or request a registration quote.

    Competitor facts from the MacroBridge public pages linked above, reviewed for bioaccess® competitive research (Aug–Oct 2026). Claims are theirs. No invented clients, prices or contacts.

  • Enlace Profesional Registro Sanitario de Dispositivos Médicos en El Salvador vs bioaccess®

    Enlace Profesional de Consultores shows up when manufacturers search for a Latin American registration holder or sanitary-registration partner. This article uses only what Enlace Profesional de Consultores publishes on its own site (enlacegt.com/registro-sanitario/registro-sanitario-de-dispositivos-medicos-en-el-salvador), then compares it with the multi-country subscription from bioaccess®. It is a practitioner comparison, not a teardown.

    What Enlace Profesional de Consultores publishes

    Enlace Profesional de Consultores is a Guatemala-based regulatory firm working in Central America and Panama since 2007, with its own offices in Guatemala, El Salvador and Panama. Its El Salvador page covers medical device registration dossiers and representation before the Superintendencia de Regulación Sanitaria (SRS), and explains that the importer must be registered with the SRS and named by the titular as authorized distributor.

    Enlace Profesional de Consultores vs bioaccess®

    Dimension Enlace Profesional de Consultores bioaccess®
    Public product SRS dossier + representation LATAM Launch Subscription: registration, in-country holder, certified translations, government fees, tecnovigilancia (import shipments quoted separately)
    Geography El Salvador page; offices in Guatemala, El Salvador and Panama 19 LATAM markets
    Public pricing None published USD 7,500 per year per country for the first device family
    Holder vs distributor Its El Salvador page says the registered importer is named by the titular as authorized distributor and appoints a responsible pharmacist; Enlace provides the dossier and representation work Holds through its own in-country entities, with defined transfer provisions; the registration is never leverage
    Bridge from a clinical trial None published Trial-to-Market Bridge: 20% off for bioaccess® clinical-trial clients

    Where each one fits

    If Central America is the whole plan and you want a Guatemala-based firm, Enlace publishes that service.

    The LATAM Launch Subscription from bioaccess® is a different product. bioaccess® registers already FDA-cleared or CE-marked devices and holds them through its own in-country entities across 19 Latin American markets, including COFEPRIS, ANVISA, INVIMA, ANMAT, ISP and DIGEMID. The published card is USD 7,500 per year per country for the first device family, with government submission fees, certified or sworn translations, the in-country titular or holder, and tecnovigilancia inside the fee (importer-of-record shipments are priced separately on the hub). Multi-country discounts are 10% at three or more countries and 15% at five or more. The registration is held for the manufacturer’s benefit, with defined transfer provisions if you ever change partners or set up your own entity.

    One country and one local partner is enough? Hire the firm that publishes that job. Several LATAM labels under one holder who is not your distributor? Start at bioaccess® market access, read the LATAM importer of record guide, try the LATAM Launch Calculator, or request a registration quote.

    Competitor facts from the Enlace Profesional de Consultores public pages linked above, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented clients, prices or contacts.

  • Registra en Panamá Registro Sanitario de Dispositivos Médicos vs bioaccess®

    Registra en Panamá shows up when manufacturers search for a Latin American registration holder or sanitary-registration partner. This article uses only what Registra en Panamá publishes on its own site (registraenpanama.com/registros-sanitarios-de-dispositivos-medicos), then compares it with multi-country market access from bioaccess®. It is a practitioner comparison, not a teardown.

    What Registra en Panamá publishes

    Registra en Panamá publishes a medical device registration page covering MINSA device registration and operating licenses. It is a dossier and permits service, and the page does not say the firm becomes the named holder.

    Registra en Panamá vs bioaccess®

    Dimension Registra en Panamá bioaccess®
    Public product MINSA device registration dossier + operating license Registration, in-country holder, certified translations, tecnovigilancia as holder (import shipments quoted separately)
    Geography Panama Published pricing in Mexico, Colombia, Brazil, Peru and Argentina; other markets quoted case by case
    Public pricing None published Two-part: one-time registration fee per country by class, then an annual holder fee from year 2 (rate card)
    Holder vs distributor See the provider’s own terms Holder under contract (own Colombian entity in Colombia; local partner elsewhere), with defined transfer provisions; the registration is never leverage
    Bridge from a clinical trial None published Same firm can run the LATAM clinical trial and then hold the commercial registration

    Where each one fits

    If you already have a Panamanian distributor who will hold the registration, a permits shop like Registra en Panamá is enough.

    bioaccess® market access is a different product. bioaccess® registers already FDA-cleared or CE-marked devices and acts as their registration holder under contract (in Colombia through its own Colombian entity; elsewhere with its local partner) across Latin American markets, including COFEPRIS, ANVISA, INVIMA, ANMAT, ISP and DIGEMID. Pricing is 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). Importer-of-record shipments are quoted separately. The registration is held for the manufacturer’s benefit, with defined transfer provisions if you ever change partners or set up your own entity.

    One country and one local partner is enough? Hire the firm that publishes that job. Several LATAM labels under one holder who is not your distributor? Start at bioaccess® market access, read the LATAM importer of record guide, try the market-access calculator, or request a registration quote.

    Competitor facts from the Registra en Panamá public pages linked above, reviewed for bioaccess® competitive research (Aug–Oct 2026). Claims are theirs. No invented clients, prices or contacts.

  • MD Consultora Registro Sanitario Perú vs bioaccess® LATAM Registration Holder

    MD Consultora shows up when manufacturers search for a Latin American registration holder or sanitary-registration partner. This article uses only what MD Consultora publishes on its own site (mdconsultora.pe/como-obtener-un-registro-sanitario), then compares it with the multi-country subscription from bioaccess®. It is a practitioner comparison, not a teardown.

    What MD Consultora publishes

    MD Consultora is a Peruvian consultancy that publishes a guide on how to obtain a registro sanitario. It offers dossier work and droguería setup, and in replies on the page says it can evaluate registering and importing through an already-constituted droguería. It does not have a dedicated holder product page.

    MD Consultora vs bioaccess®

    Dimension MD Consultora bioaccess®
    Public product DIGEMID dossier + droguería setup LATAM Launch Subscription: registration, in-country holder, certified translations, government fees, tecnovigilancia (import shipments quoted separately)
    Geography Peru 19 LATAM markets
    Public pricing None published USD 7,500 per year per country for the first device family
    Holder vs distributor Explains that a DIGEMID-authorized droguería holds the registration; helps clients set up their own droguería or evaluate registering through one that already exists Holds through its own in-country entities, with defined transfer provisions; the registration is never leverage
    Bridge from a clinical trial None published Trial-to-Market Bridge: 20% off for bioaccess® clinical-trial clients

    Where each one fits

    If you plan to set up your own Peruvian droguería, a consultancy that does droguería setup is the right first call.

    The LATAM Launch Subscription from bioaccess® is a different product. bioaccess® registers already FDA-cleared or CE-marked devices and holds them through its own in-country entities across 19 Latin American markets, including COFEPRIS, ANVISA, INVIMA, ANMAT, ISP and DIGEMID. The published card is USD 7,500 per year per country for the first device family, with government submission fees, certified or sworn translations, the in-country titular or holder, and tecnovigilancia inside the fee (importer-of-record shipments are priced separately on the hub). Multi-country discounts are 10% at three or more countries and 15% at five or more. The registration is held for the manufacturer’s benefit, with defined transfer provisions if you ever change partners or set up your own entity.

    One country and one local partner is enough? Hire the firm that publishes that job. Several LATAM labels under one holder who is not your distributor? Start at bioaccess® market access, read the LATAM importer of record guide, try the LATAM Launch Calculator, or request a registration quote.

    Competitor facts from the MD Consultora public pages linked above, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented clients, prices or contacts.

  • Global Farma Titularidad de Registros DIGEMID vs bioaccess® LATAM Market Access

    Global Farma shows up when manufacturers search for a Latin American registration holder or sanitary-registration partner. This article uses only what Global Farma publishes on its own site (globalfarma.pe/services/titularidad-de-registros), then compares it with the multi-country subscription from bioaccess®. It is a practitioner comparison, not a teardown.

    What Global Farma publishes

    Global Farma is a Peruvian company whose titularidad de registros page offers to hold registrations for pharmaceuticals, cosmetics, medical devices and sanitary products, and to import through its own droguería.

    Global Farma vs bioaccess®

    Dimension Global Farma bioaccess®
    Public product DIGEMID registration holder + import through its droguería LATAM Launch Subscription: registration, in-country holder, certified translations, government fees, tecnovigilancia (import shipments quoted separately)
    Geography Peru 19 LATAM markets
    Public pricing None published USD 7,500 per year per country for the first device family
    Holder vs distributor Acts as the titular responsible before DIGEMID and imports through its own droguería Holds through its own in-country entities, with defined transfer provisions; the registration is never leverage
    Bridge from a clinical trial None published Trial-to-Market Bridge: 20% off for bioaccess® clinical-trial clients

    Where each one fits

    If Peru is the only market and you want the titular and the importing droguería in one local company, Global Farma covers it.

    The LATAM Launch Subscription from bioaccess® is a different product. bioaccess® registers already FDA-cleared or CE-marked devices and holds them through its own in-country entities across 19 Latin American markets, including COFEPRIS, ANVISA, INVIMA, ANMAT, ISP and DIGEMID. The published card is USD 7,500 per year per country for the first device family, with government submission fees, certified or sworn translations, the in-country titular or holder, and tecnovigilancia inside the fee (importer-of-record shipments are priced separately on the hub). Multi-country discounts are 10% at three or more countries and 15% at five or more. The registration is held for the manufacturer’s benefit, with defined transfer provisions if you ever change partners or set up your own entity.

    One country and one local partner is enough? Hire the firm that publishes that job. Several LATAM labels under one holder who is not your distributor? Start at bioaccess® market access, read the LATAM importer of record guide, try the LATAM Launch Calculator, or request a registration quote.

    Competitor facts from the Global Farma public pages linked above, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented clients, prices or contacts.

  • Mi Regulatorios ISP Chile Registration vs bioaccess® LATAM Registration Holder

    Mi Regulatorios shows up when manufacturers search for a Latin American registration holder or sanitary-registration partner. This article uses only what Mi Regulatorios publishes on its own site (miregulatorios.cl), then compares it with the multi-country subscription from bioaccess®. It is a practitioner comparison, not a teardown.

    What Mi Regulatorios publishes

    Mi Regulatorios is a Chilean regulatory practice led by María Inés Silva. Its homepage covers ISP registrations for cosmetics, medical devices, pharmaceuticals and disinfectants, company inscription and warehouse (bodega) resolutions. It is a dossier service, and the site does not present a separate holder product.

    Mi Regulatorios vs bioaccess®

    Dimension Mi Regulatorios bioaccess®
    Public product ISP dossiers, company inscription, bodega resolution LATAM Launch Subscription: registration, in-country holder, certified translations, government fees, tecnovigilancia (import shipments quoted separately)
    Geography Chile 19 LATAM markets
    Public pricing None published USD 7,500 per year per country for the first device family
    Holder vs distributor Handles changes of manufacturer or titular before ISP and registers importers, distributors and titulares on the ISP platform; no holder product on the site Holds through its own in-country entities, with defined transfer provisions; the registration is never leverage
    Bridge from a clinical trial None published Trial-to-Market Bridge: 20% off for bioaccess® clinical-trial clients

    Where each one fits

    If you already have a Chilean importer and only need the ISP paperwork done, a dossier shop like Mi Regulatorios is the right size.

    The LATAM Launch Subscription from bioaccess® is a different product. bioaccess® registers already FDA-cleared or CE-marked devices and holds them through its own in-country entities across 19 Latin American markets, including COFEPRIS, ANVISA, INVIMA, ANMAT, ISP and DIGEMID. The published card is USD 7,500 per year per country for the first device family, with government submission fees, certified or sworn translations, the in-country titular or holder, and tecnovigilancia inside the fee (importer-of-record shipments are priced separately on the hub). Multi-country discounts are 10% at three or more countries and 15% at five or more. The registration is held for the manufacturer’s benefit, with defined transfer provisions if you ever change partners or set up your own entity.

    One country and one local partner is enough? Hire the firm that publishes that job. Several LATAM labels under one holder who is not your distributor? Start at bioaccess® market access, read the LATAM importer of record guide, try the LATAM Launch Calculator, or request a registration quote.

    Competitor facts from the Mi Regulatorios public pages linked above, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented clients, prices or contacts.