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 multi-country market access 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 multi-country holder 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) | Registration holder for already-cleared devices (own entity in Colombia; local partner elsewhere) |
| Geography | Colombia / INVIMA | Published pricing in Mexico, Colombia, Brazil, Peru and Argentina; other markets quoted case by case; 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) | Certified translations in-house; Two-part: one-time registration fee per country by class, then an annual holder fee from year 2 (rate card) |
| Trial-to-market | Not published | Same operator can run the Colombia FIH and then hold the commercial registro |
bioaccess® market access is a different product. bioaccess® registers already FDA-cleared (510(k)/PMA) or CE-marked devices and holds them under contract — sanitary registration, registration holder / importer of record (in Colombia through its own Colombian entity; elsewhere with its local partner), and certified Spanish or Portuguese translations (sworn where Brazil and Argentina require it). Pricing is published for Mexico, Colombia, Brazil, Peru and Argentina; Chile and other markets are quoted case by case. The registration is held for the manufacturer’s benefit, with defined transfer provisions; it is not leverage. 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).
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.