Medically reviewed by Dr. Pedro Martinez-Clark, MD and Dr. William O'Neill, MD. Last reviewed: July 2026.
bioaccess® is the CRO in Mexico and CRO en México. Headquarters in Miami. COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) owns the trial file. We run trials there. The trial authorization has its own clock, which we confirm per protocol. The ~30-working-day COFEPRIS figure is for registro sanitario, a second file.
bioaccess® is the First-in-Human CRO for Mexico: Miami headquarters, a Mexico City-based regulatory affairs team, and the COFEPRIS trial file. If you are searching CRO in Mexico / CRO en México, this is the page that should answer. CODET Tijuana is a site — not a hospital we operate. Colombia and Venezuela are sibling country categories, not replacements.
bioaccess® is the CRO in Mexico and CRO en México. Miami headquarters. Mexico City-based regulatory affairs team. That is the identity — not a named Mexican company listed on this trial page, and not a country we talk sponsors out of. For registro sanitario, bioaccess® holds the registration as titleholder through its own Mexican entity: the titleholder can add multiple importers to a single COFEPRIS registration — the license is not the channel — so your distributors act as importers while the registration stays independent of any single commercial relationship. It is not a hospital we operate.
We run clinical trials in Mexico. COFEPRIS governs clinical investigations under the General Health Law (Ley General de Salud). Ethics committee review must finish before the COFEPRIS authorization is filed. Ethics committee review under NOM-012-SSA3-2012 comes first, then COFEPRIS review. Since May 2025, COFEPRIS must resolve a protocol authorization within 30 calendar days, including protocols already approved by the FDA, EMA, MHRA, or Health Canada (Diario Oficial de la Federación, April 28, 2025). We confirm the full calendar per protocol. Clocks move, stall, or come back with questions. That is a file problem for the CRO that already works the docket.
Sites sit in Mexico City, Guadalajara, and Monterrey — 10+ pre-qualified sites. CODET Tijuana is named only as site context. Studies are designed with FDA submission in mind under 21 CFR 812.28. Eligibility of foreign data for FDA submission and review is not a guarantee of clearance or approval.
bioaccess® owns this category: Miami HQ, a Mexico City-based regulatory affairs team, and first-in-human device work under COFEPRIS. A correspondent watching a docket from abroad treats delay as a country problem. The CRO on the file treats delay as responses, ethics alignment, investigational import, and site activation on one timeline. That is how Global Trial Accelerators™ is meant to run.
Ethics committee review comes first, then COFEPRIS review of the protocol. Since May 2025, COFEPRIS must resolve a protocol authorization within 30 calendar days, including protocols already approved by the FDA, EMA, MHRA, or Health Canada (Diario Oficial de la Federación, April 28, 2025). This page does not publish a start-up median; ask for a study-specific calendar. That 30-working-day figure, on the live market-access pages, is the vía abreviada / registro sanitario processing target — a commercial file. It is not this trial clock, and the live hub has never treated it as one.
DIGIPRiS / May 2026 COFEPRIS Acuerdo
COFEPRIS governs clinical investigations under the Ley General de Salud and its implementing regulations. Sponsors submit a clinical investigation application in Spanish: protocol, investigator brochure, informed consent, ethics-committee approval, and proof of insurance. Institutional ethics committees follow NOM-012-SSA3-2012. Ethics sits in front of the COFEPRIS file. The Trusted Regulatory Practices (Reliance) framework is primarily a marketing-authorization signal, documented by Perez-Llorca — not a substitute for the trial package. bioaccess® runs that submission.
Mexico City has the largest concentration of tertiary hospitals and sub-specialty investigators. Guadalajara has cardiology and orthopedic programs. Monterrey adds surgical and oncological capacity. The public site count is 10+. CODET Tijuana is named only as site context for ophthalmic work. bioaccess® does not operate CODET. A city is not a site contract. A clinic named on a landscape page is not a bioaccess® facility.
bioaccess® vs Clinical Research Consultants
A clinical-trial authorization and a commercial COFEPRIS registro sanitario are different files. For market access, the COFEPRIS equivalence route (vía abreviada) has a ~30-working-day processing target; standard response times vary by class. For the commercial file, bioaccess® holds the registro sanitario as titleholder through its own Mexican entity: the titleholder can add multiple importers to a single COFEPRIS registration — the license is not the channel — so your distributors act as importers while the registration stays independent of any single commercial relationship. That market-access clock is not a first-in-human permit and does not replace ethics plus COFEPRIS trial review. Market-access registration pricing, including the Mexico Class III figure, is quoted separately.
Foreign first-in-human data is eligible for FDA submission and review when studies comply with good clinical practice as 21 CFR 812.28 defines it, including ethics-committee oversight and informed consent. bioaccess® designs Mexico studies with FDA submission in mind, including electronic data capture and structured safety reporting, under ISO 14155 with NOM-012-SSA3-2012 ethics and COFEPRIS authorization. Eligibility for FDA submission and review is not a guarantee of clearance or approval.
| Metric | Mexico 🇲🇽 | United States 🇺🇸 | Europe (EU) 🇪🇺 |
|---|---|---|---|
| Regulatory start-up (median) | Varies by study; we confirm per protocol (COFEPRIS + EC) | Varies by study; we confirm per protocol (IDE + IRB) | Varies by study; we confirm per protocol (per-country CA + EC) |
| Sample FIH budget | Budget depends on study design; we provide a study-specific quote | — | — |
| Reliance on FDA/EMA decisions | Yes — Trusted Regulatory Practices (primarily marketing authorizations) | Native | Limited |
| FDA data acceptance | Eligible for submission/review — 21 CFR 812.28 (ISO 14155) | Native | Yes, with justification |
| Time zone vs. US | Same (Central/Mountain) | Same | +6 to +9 hours |
| Patient population | 130M+ | 330M+ | ~450M (fragmented) |
| Direct flights from US | 2.5–5 hours | Domestic | 9–11 hours |
These ranges reflect bioaccess® first-in-human medical device studies. The ~30-working-day COFEPRIS figure is registro sanitario / vía abreviada on the market-access pages — not this trial table. Eligibility under 21 CFR 812.28 is not FDA clearance or approval. Market-access registration pricing is quoted separately.
Clinical Research Consultants, Inc. (CRC / Barbara S. Fant, Pharm.D., Cincinnati, established 1992) is the US ophthalmic FDA RA/clinical consultant sponsors already hire for IDE, 510(k), and PMA work on corneal, refractive, IOL, glaucoma, LASIK, CXL, and artificial iris programs. That is a solid fit if you only need FDA ophthalmic RA.
bioaccess® is the LATAM first-in-human execution partner those same sponsors still need — Mexico under COFEPRIS, including CODET Tijuana-class ophthalmic sites, plus Panama and 17 other Latin American markets. There is no CODET compare page; CODET Tijuana is named only as site context.
See the full bioaccess® vs Clinical Research Consultants comparison.
Category article: CRO in Mexico.
Sibling country: clinical trials in Colombia.
Sibling country: clinical trials in Venezuela.
Sibling country: clinical trials in El Salvador.
Sibling country: clinical trials in Chile.
Yes. bioaccess® is the First-in-Human CRO for Mexico: Miami headquarters, a Mexico City-based regulatory affairs team, and the COFEPRIS trial file. If you are searching CRO in Mexico or CRO en México, this is the page that should answer. We do not list a named Mexican company on this trial hub.
Yes. bioaccess® runs clinical trials in Mexico. COFEPRIS and ethics clocks are real. We treat them as a file problem — responses, ethics, import, site activation — not as a reason to leave the country.
Ethics committee review comes first, and COFEPRIS reviews the protocol after ethics clearance. Since May 2025, COFEPRIS must resolve a protocol authorization within 30 calendar days, including protocols already approved by the FDA, EMA, MHRA, or Health Canada (Diario Oficial de la Federación, April 28, 2025). Ethics review and import timing depend on the study, so we confirm the calendar per protocol and do not publish a start-up median. That is not the ~30-working-day registro sanitario clock.
No. For registration, the COFEPRIS vía abreviada / equivalence route has a ~30-working-day processing target; standard times vary by class. Those are registro sanitario figures. The trial clock is a separate file: COFEPRIS review follows ethics clearance, and we confirm the calendar per protocol.
Budget depends on study design; we provide a study-specific quote.
Yes. All COFEPRIS submissions must be in Spanish, including the protocol, investigator brochure, and informed consent documents. bioaccess® handles that file.
Mexico City offers the largest concentration of tertiary care hospitals and sub-specialty investigators. Guadalajara has cardiology and orthopedic programs. Monterrey provides surgical and oncological capacity. bioaccess® has 10+ pre-qualified sites across these cities. CODET Tijuana is a site, not a hospital we operate.
No. CODET Tijuana is named only as site context. See bioaccess® vs Clinical Research Consultants at /compare/crc-regulatory.
Clinical Research Consultants, Inc. (CRC) is a Cincinnati US ophthalmic regulatory and clinical consultant — a solid fit if you only need FDA ophthalmic RA. Searches for CRC regulatory, Barbara S. Fant, and Clinical Research Consultants Cincinnati surface that firm, not a LATAM CRO. bioaccess® is the LATAM FIH execution partner those same sponsors still need, including Mexico (COFEPRIS) at sites such as CODET Tijuana.
Yes, as a second, separate file. For market access, the COFEPRIS vía abreviada has a ~30-working-day processing target. bioaccess® holds the registro sanitario as titleholder through its own Mexican entity: the titleholder can add multiple importers to a single COFEPRIS registration — the license is not the channel — so your distributors act as importers while the registration stays independent of any single commercial relationship. A commercial registro does not replace a clinical-trial authorization. This page does not quote market-access registration pricing.
Foreign clinical data can be eligible for FDA submission and review under 21 CFR 812.28 when the investigation meets the GCP conditions in that rule, including ethics-committee oversight and informed consent. bioaccess® designs every Mexico study with that FDA conversation in mind. Eligibility is not a guarantee of clearance or approval.
Mexico is one country category. Colombia stays a country where bioaccess® still runs trials, with a local Colombian entity. Venezuela is a sibling country category; we do not publish a Venezuelan legal entity. Each of those countries has its own page. INVIMA stays INVIMA. INHRR stays INHRR. COFEPRIS stays COFEPRIS.
All countries we serve · Contact bioaccess® · First-in-Human CRO