Vexpro Consultores (Bogotá) publishes a sentence most INVIMA consultancies do not: “Actuamos como titulares holder de sus registros sanitarios en Colombia.” That is a one-country holder product, not only a dossier shop. The homepage is vexproconsultores.com (public wording confirmed 23 August 2026). This article uses only that offer language. It does not copy manufacturer names from their site. Then it explains when the multi-country subscription from bioaccess® is the better holder.
What Vexpro publishes (offer only)
Public positioning: regulatory BPO for national and international companies; titularidad and legal representation before INVIMA; they act as titulares / holder of sanitary registrations in Colombia, including a cosmetics hosting role under Comunidad Andina NSO rules; a medical-device practice covering a range of device types (implants, electromechanical devices, consumables, software as a medical device) with sanitary-registration management and quality assurance. ConnectAmericas lists the legal name VEXPRO CONSULTORES LTDA and describes INVIMA registros plus quality-norm advisory across several product classes.
INVIMA practice is messy in public commentary. Some shops say the foreign manufacturer can remain titular if a Colombian representante legal is named; others sell themselves as the titular holder. Vexpro sells the second sentence. Either way, an in-country entity — and often a CCAA-licensed importer — appears on the record. INVIMA explicitly contemplates “un titular con varios importadores” on one registro sanitario. That is why an independent holder (or an independent legal representative plus a licensed importer that is not the exclusive distributor) is the structure that keeps the channel replaceable. See Colombia — INVIMA.
What Vexpro’s public holder line does not do: publish a 19-country own-entity subscription, include government fees and certified translations in one annual fee, or offer a trial-to-market bridge with a FIH CRO. They are a Colombia titular / BPO. Treat them as that.
Vexpro vs bioaccess®
| Dimension | Vexpro Consultores | bioaccess® |
|---|---|---|
| Public product | “Titulares holder” + INVIMA BPO (devices among other classes) | LATAM Launch Subscription for already-cleared devices |
| Geography | Colombia / INVIMA | 19 LATAM markets; Bogotá regional office + local Colombian entity |
| Importer split | Not published as a multi-country IOR map | INVIMA multi-importer rule documented on the IOR page; holder not leverage |
| Bundle | Country RA / holder (no published all-in LATAM fee) | Gov fees + certified translations included |
| Trial-to-market | Not published | Same operator can run the Colombia FIH and then hold the commercial registro; 20% Bridge |
The LATAM Launch Subscription from bioaccess® is a different product. bioaccess® registers already FDA-cleared (510(k)/PMA) or CE-marked devices and holds them through its own in-country entities — sanitary registration, registration holder / importer of record, certified Spanish or Portuguese translations (sworn where Brazil and Argentina require it), and government submission fees, inside one annual subscription per country and device family. Public coverage is described as 19 LATAM markets. The registration is held for the manufacturer’s benefit, with defined transfer provisions; it is not leverage. Clinical-trial clients of bioaccess® receive the published Trial-to-Market Bridge (20% off). Specific rates are under review; contact bioaccess® for a quote.
bioaccess® still runs clinical trials in Colombia and treats commercial registro sanitario as a separate live service — not a substitute for the trial, and not something the trial team has to re-learn with a second vendor. Vexpro is a fair INVIMA titular for a Colombia-only commercial file. bioaccess® is the operator when Colombia is one market in a multi-country hold, or when the manufacturer already used bioaccess® as the FIH CRO.
If the plan is one country and a homegrown titular is enough, hire the shop that actually publishes that job. If the plan is several LATAM labels under one holder who is not the distributor, start at bioaccess® market access or request a registration quote.
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