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 2.8-month median already on this hub is the trial clock. The ~30-working-day COFEPRIS figure is 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 already named on this hub. That is the identity — not a named Mexican company listed on this trial page, and not a country we talk sponsors out of. The live COFEPRIS market-access page already says bioaccess® holds registrations through our own Mexican entity. That is a holder fact for registro sanitario. 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. This hub already publishes ethics at 4–6 weeks under NOM-012-SSA3-2012, COFEPRIS review at 4–8 weeks after ethics clearance, and a 2.8-month median start-up (NIH ClinRegs). 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 already listed on this page. 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.
This hub already publishes a 2.8-month median start-up (NIH ClinRegs), ethics at 4–6 weeks, and COFEPRIS review at 4–8 weeks after ethics clearance. We will not invent a new median. Ask for a study-specific calendar. llms.txt lists Mexico as COFEPRIS (30-day approval pathway). 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 already described on this hub 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. The live Mexico COFEPRIS market-access page already puts the equivalence route (vía abreviada) at a ~30-working-day processing target, standard response times at about 30 / 35 / 60 working days by class, and says bioaccess® holds the registration through our own Mexican entity. That market-access clock is not a first-in-human permit and does not replace ethics plus COFEPRIS trial review. Say at kickoff if you need both. This hub does not quote LATAM Launch subscription pricing, including the Mexico Class III figure.
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) | ~2.8 months (COFEPRIS + EC) | 6–12 months (IDE + IRB) | 3–6 months (per-country CA + EC) |
| Cost per patient | $18K–$30K | $40K–$75K | $35K–$60K |
| 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 |
Ranges already published on this hub reflect bioaccess® first-in-human medical device studies. The 2.8-month median is attributed to NIH ClinRegs. The ~30-working-day COFEPRIS figure is registro sanitario / vía abreviada on the market-access pages — not this trial table. Headline ~40% faster / ~30% lower cost is experience since 2010, not a formal study. Eligibility under 21 CFR 812.28 is not FDA clearance or approval. This hub does not quote LATAM Launch subscription pricing.
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. This page does not claim bioaccess® operated the public Ocumetics Mexico FIH or closed Adaptilens ADP-FIH-002.
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.
This hub already publishes COFEPRIS review at 4–8 weeks after ethics committee clearance, ethics at 4–6 weeks, and a 2.8-month median start-up (NIH ClinRegs). Ask for a study-specific calendar. We will not invent a new median here. That is not the ~30-working-day registro sanitario clock.
No. llms.txt lists Mexico as COFEPRIS (30-day approval pathway) for market access. The live Mexico COFEPRIS registration page already puts the vía abreviada / equivalence route at a ~30-working-day processing target and standard times at about 30 / 35 / 60 working days by class. Those are registro sanitario figures. This hub's trial clock stays 2.8 months median, 4–8 weeks COFEPRIS after ethics.
This hub already publishes $18,000–$30,000 per patient, depending on device complexity and therapeutic area. A 10-patient FIH study typically costs $280K–$400K — compared to $750K–$1.5M in the United States. Headline ~40% faster / ~30% lower cost versus typical US/EU programs is experience since 2010, not a formal study.
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. This page does not claim bioaccess® operated the public Ocumetics Mexico FIH or closed Adaptilens. 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. The live Mexico COFEPRIS market-access page already puts the vía abreviada at a ~30-working-day processing target and says bioaccess® holds the registration through our own Mexican entity. A commercial registro does not replace a clinical-trial authorization. This page does not quote LATAM Launch subscription 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. Do not read this page as a replacement for those hubs. INVIMA stays INVIMA. INHRR stays INHRR. COFEPRIS stays COFEPRIS.
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