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 two-part registration pricing across 19 markets, with own in-country entities, government fees and in-house translations under published two-part pricing (one-time registration fee plus annual holder fee), 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 (two-part registration pricing) | 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 | Two-part pricing: one-time registration fee by country/class + annual holder fee from year 2 — government submission fees + in-house certified/sworn translations + in-country holder/IOR + regulatory liaison included. | "Cost-effective annual support for BRH Service" (Freyr wording) — not an all-in government-fee + certified-translation subscription. |
| Registration holder / importer of record | bioaccess® is the contractual registration holder across 19 LATAM markets, working with our local partners in-country; 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 registration fees 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® market access registration uses published two-part pricing (one-time registration fee plus annual holder fee) (government fees and certified translations included). 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 two-part registration pricing. 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 published two-part pricing 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 published two-part pricing 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)