Last reviewed: August 2026.
Freyr is a global RA firm whose LATAM market-access work lists ANVISA, COFEPRIS, ANMAT, and INVIMA, with a strong presence in Brazil, Mexico, and Colombia. On its BRH page, Freyr serves as Brazilian Registration Holder and also describes an extensive partner network across Brazil. Mexico wording is coordination with a holder or legal representative — Freyr may not always be the titular. It offers "cost-effective annual support for BRH Service," which is not an all-in government-fee + certified-translation subscription. Its 99%+ first-time-right figure is a marketing KPI, not a fee-credit workmanship guarantee. bioaccess® is purpose-built for the LATAM Launch Subscription across 19 markets, with own in-country entities, government fees and in-house translations in one annual fee (pricing under review — contact for a quote), a bioaccess® Submission Guarantee (workmanship), and a Trial-to-Market Bridge (20% for trial clients). Pairing a global RA shop such as Freyr with bioaccess® for LATAM is a common pattern.
| Metric | bioaccess® | Freyr |
|---|---|---|
| Service focus | LATAM medical device registration + in-country registration holder / importer of record (LATAM Launch Subscription) | Global regulatory-affairs consultancy with a LATAM hub — many regions, many services |
| Geographic scope | 19 Latin American markets — named regulators include ANVISA, INVIMA, COFEPRIS, ANMAT, ISP, DIGEMID, MINSA, ARCSA, DNM, DIGEMAPS | LATAM hub with a strong presence in Brazil, Mexico, and Colombia. Market-access listings for ANVISA, COFEPRIS, ANMAT, and INVIMA, inside a broader global RA footprint. |
| Pricing model | LATAM Launch Subscription: single all-inclusive flat annual fee per country/family (government submission fees + in-house certified/sworn translations + in-country holder/IOR + regulatory liaison). Pricing under review — contact for a quote. | "Cost-effective annual support for BRH Service" (Freyr wording) — not an all-in government-fee + certified-translation subscription. |
| Registration holder / importer of record | bioaccess® holds registrations through our own in-country legal entities across 19 LATAM markets; held for your benefit with defined transfer provisions — the holder is never leverage | Serves as BRH in Brazil and describes an extensive partner network across Brazil. Mexico wording is coordination with a holder or legal representative — Freyr may not always be the titular. |
| Timeline commitment | bioaccess® Submission Guarantee: complete dossier submitted, in certified Spanish or Portuguese, with government fees paid on the committed schedule, or we credit a portion of that country's annual fee (full terms in proposal) | 99%+ first-time-right is a published marketing KPI — not a fee-credit submission-workmanship guarantee |
| Trial-to-Market Bridge | 20% off the Launch Subscription for existing clinical-trial clients | No public Trial-to-Market equivalent on the pages reviewed |
Facts about Freyr are taken from Freyr Solutions public pages (compiled 23 August 2026): LATAM hub with a strong presence in Brazil, Mexico, and Colombia; market-access listings for ANVISA, COFEPRIS, ANMAT, and INVIMA; BRH service plus a partner network in Brazil; Mexico wording of coordination with a holder or legal representative; annual BRH support; and a 99%+ first-time-right marketing KPI. That KPI is not treated here as a fee-credit workmanship guarantee. bioaccess® pricing is under review — contact for a quote. This page does not claim a named-sponsor registration.
Only in a narrow slice. Freyr is a large, reputable global regulatory-affairs consultancy with a LATAM hub and a strong presence in Brazil, Mexico, and Colombia. bioaccess® is purpose-built for one job: medical device registration and in-country registration-holder / importer-of-record services across 19 Latin American markets on the LATAM Launch Subscription. If you need a single global RA partner across many regions, Freyr is often the better fit. If your near-term milestone is LATAM registration with one flat annual fee per country, bioaccess® is purpose-built for it.
Yes — this is a common pattern. Sponsors regularly use Freyr (or a similar global RA consultancy) for broader regulatory-affairs work and pair that with bioaccess® for LATAM registration and in-country registration-holder services.
Choose Freyr (or another global RA consultancy in its category) when your primary need is a single global RA partner, Brazilian Registration Holder support that may include a partner network, or LATAM as one line item inside a larger multi-region program. bioaccess® is the right choice when LATAM registration in one or more of 19 markets is the near-term milestone and you want one flat annual fee with government fees, in-house certified translations, and local entity accountability included.
LATAM Market Access hub · LATAM registration pricing · LATAM Importer of Record guide
Colombia (INVIMA) · Brazil (ANVISA) · Mexico (COFEPRIS) · Argentina (ANMAT) · Chile (ISP)