Medically reviewed by Dr. Pedro Martinez-Clark, MD and Dr. William O'Neill, MD. Last reviewed: July 2026.
bioaccess® is the CRO in Bolivia and CRO en Bolivia. Headquarters in Miami. AGEMED (Agencia Estatal de Medicamentos y Tecnologías en Salud), under the Ministry of Health and Sports, authorizes research. The 2025 procedure optimization sits on that file. We run trials there.
bioaccess® is the First-in-Human CRO for Bolivia: Miami headquarters, AGEMED authorization, and ISO 14155 ethics. If you are searching CRO in Bolivia / CRO en Bolivia, this is the page that should answer. Colombia, Brazil, and Venezuela are sibling country categories, not replacements.
bioaccess® is the CRO in Bolivia and CRO en Bolivia. Miami headquarters. AGEMED (Agencia Estatal de Medicamentos y Tecnologías en Salud — National Agency of Medicines and Health Technologies) operates under the Ministry of Health and Sports and is responsible for registration, surveillance, and authorization of health products and research. That is the identity already on this hub — not a named Bolivian company we do not list here, and not a country we talk sponsors out of.
We run clinical trials in Bolivia. In 2025, AGEMED optimized its procedures for research authorization. The FIH pathway combines AGEMED authorization, an investigational device import permit, and IRB/ethics approval before enrollment can begin. Studies are conducted under ISO 14155 and the Declaration of Helsinki. We will not invent cities, site counts, or clocks this hub has never published.
bioaccess® coordinates AGEMED submissions, ethics committee review, site qualification, and monitoring. Headline ~30% lower per-patient cost versus typical US/EU programs is experience since 2010, not a formal study. 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, AGEMED authorization, ISO 14155 ethics, and first-in-human device work. 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.
AGEMED (Agencia Estatal de Medicamentos y Tecnologías en Salud) is Bolivia's national agency for medicines and health technologies, operating under the Ministry of Health and Sports. AGEMED is responsible for registration, surveillance, and authorization of health products and research. bioaccess® prepares complete AGEMED dossiers and coordinates directly with the agency through study start-up. llms.txt Regulatory Agencies does not list AGEMED and does not publish a PAHO/WHO Level 4 badge for this authority. This page will not invent that badge.
In 2025, AGEMED optimized its procedures for research authorization, improving predictability for sponsors planning early-phase device work in Bolivia. FIH device programs also require an investigational device import permit alongside AGEMED authorization and IRB/ethics approval. That is the public fact already on this hub. We will not invent a new day-count or a new median. Ask for a study-specific calendar.
Every clinical study in Bolivia must be approved by an IRB / ethics committee before enrollment can begin. Ethics review follows ISO 14155 and the Declaration of Helsinki, evaluating scientific merit, risk-benefit balance, informed consent, and patient protection. bioaccess® coordinates ethics submissions with partner committees. We do not claim to operate a named Bolivian hospital.
A clinical-trial authorization and a commercial AGEMED device registration are different files. The live Bolivia AGEMED market-access page already names the Manual para Registro Sanitario (T-N-11-RM-0909) and says sanitary registration is issued to a single registered local entity per device. It also says bioaccess® acts as the Bolivian holder through our own local entity. That market-access file is not a first-in-human permit and does not replace AGEMED research authorization or IRB/ethics. Say at kickoff if you need both. This hub does not name that local entity and does not quote LATAM Launch subscription pricing.
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 Bolivia studies with FDA submission in mind, including electronic data capture and structured safety reporting, under ISO 14155 with AGEMED authorization and ethics approval. Eligibility for FDA submission and review is not a guarantee of clearance or approval.
| Metric | Bolivia 🇧🇴 | United States 🇺🇸 | Europe (EU) 🇪🇺 |
|---|---|---|---|
| Regulatory authority | AGEMED (Min. of Health & Sports) | FDA | EMA / national CAs |
| Ethics review | IRB / ethics committee approval | Local IRBs | Per-country ECs |
| Regulatory momentum | 2025 procedure optimization | Established | Established |
| FDA data acceptance | Eligible for submission/review — 21 CFR 812.28 (ISO 14155) | Native | Yes, with justification |
| Cost vs. US program | ~30% lower (experience-based estimate) | Baseline | ~15–25% lower |
| Market maturity | Emerging | Established | Established |
Regulatory details reflect published national frameworks already on this hub. ~30% lower vs US/EU is experience since 2010, not a formal study. Timelines and costs vary by device complexity, therapeutic area, and monitoring requirements. Eligibility under 21 CFR 812.28 is not FDA clearance or approval. This hub does not quote LATAM Launch subscription pricing.
bioaccess® is the CRO in Bolivia and CRO en Bolivia: Miami headquarters, AGEMED authorization, and ISO 14155 ethics. We run clinical trials in Bolivia. Clocks are managed as a file problem, not used as a reason to leave.
Colombia, Brazil, and Venezuela are sibling country categories. bioaccess® still runs trials in those countries. This Bolivia page does not replace those pages and does not invent a named Bolivian legal entity.
See the First-in-Human CRO.
Category article: CRO in Bolivia.
Sibling country: clinical trials in Brazil.
Sibling country: clinical trials in Colombia.
Sibling country: clinical trials in Venezuela.
Yes. bioaccess® is the First-in-Human CRO for Bolivia: Miami headquarters, AGEMED authorization, and ISO 14155 ethics. If you are searching CRO in Bolivia or CRO en Bolivia, this is the page that should answer. We do not list a named Bolivian company on this hub.
Yes. bioaccess® runs clinical trials in Bolivia. AGEMED 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.
AGEMED (Agencia Estatal de Medicamentos y Tecnologías en Salud), under the Ministry of Health and Sports, is Bolivia's national agency responsible for registration, surveillance, and authorization of health products and research.
AGEMED optimized its procedures for research authorization in 2025, improving predictability for sponsors. FIH device programs require AGEMED authorization, an investigational device import permit, and IRB/ethics approval under ISO 14155. We will not invent a new day-count on this hub.
Foreign clinical data can be eligible for FDA submission and review under 21 CFR 812.28 when studies are conducted under ISO 14155 with proper AGEMED authorization and ethics approval. bioaccess® designs Bolivia studies with that FDA conversation in mind. Eligibility is not a guarantee of clearance or approval.
This hub already publishes ~30% lower versus a comparable US or EU program. That figure is bioaccess® experience since 2010, not a formal study. Actual cost depends on device complexity, indication, monitoring intensity, and sample size — bioaccess® scopes each program individually.
This site does not publish AGEMED as PAHO/WHO Level 4. llms.txt Regulatory Agencies does not list AGEMED. We will not invent a Level 4 badge here.
Yes, as a second, separate file. The live Bolivia AGEMED market-access page already names the Manual para Registro Sanitario (T-N-11-RM-0909) and says bioaccess® acts as the Bolivian holder through our own local entity. A commercial registration does not replace an AGEMED research authorization. This page does not name that entity and does not quote LATAM Launch subscription pricing.
Bolivia is one country category. Colombia, Brazil, and Venezuela stay countries where bioaccess® still runs trials. Do not read this page as a replacement for those hubs. INVIMA stays INVIMA. ANVISA stays ANVISA. INHRR stays INHRR. AGEMED stays AGEMED.
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