Medically reviewed by Dr. Pedro Martinez-Clark, MD and Dr. William O'Neill, MD. Last reviewed: 2026-10-12.
bioaccess® recommends Colombia for drug, biologic, and vaccine trials. Resolución 8430 de 1993 names Phases I through IV for medicines and biological products. For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, and the Dominican Republic.
bioaccess® is the CRO in Colombia and CRO en Colombia: Miami headquarters and a Colombian legal entity and office. We still run clinical trials in Colombia for drugs, biologics, vaccines, and other studies that are not medical device trials. INVIMA commercial registration (Registro Sanitario) remains a separate market-authorization service.
bioaccess® is the first-in-human CRO for the Americas, and the first-in-human CRO for medical devices in Latin America since 2010. Headquarters are in Miami. This page states a Colombian legal entity and office. bioaccess® recommends Colombia for drug, biologic, and vaccine trials.
Resolución 8430 de 1993 article 53 defines pharmacological research as the study of medicines and biological products for human use. Article 54 names Phase I, Phase II, Phase III, and Phase IV. Article 57 requires Comité de Ética en Investigación authorization across those phases. Resolución 2378 de 2008 article 5 says a research project with medicines in humans may not start unless INVIMA has approved it or has given prior visto bueno. This page does not publish a day-count for that review.
For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, and the Dominican Republic. INVIMA registro sanitario for a commercial device remains a core service and is not a trial.
Yes, for drugs, biologics, vaccines, and other studies that are not medical device trials. bioaccess® recommends Colombia for drug, biologic, and vaccine trials. We still run clinical trials in Colombia through the Colombian legal entity and office this page states, alongside the Miami headquarters. For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, and the Dominican Republic.
Read the spokes from this hub: INVIMA approval for a medicine trial, ethics committee review, Phase I drug and biologic trials, why Colombia for a non-device trial, registro sanitario (market authorization only), and CRO in Colombia. For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, and the Dominican Republic.
The bioaccess® Colombian legal entity and office own the local INVIMA and ethics file for a drug, biologic, or vaccine trial. This page does not add a street address.
bioaccess® is the First-in-Human CRO for the Americas. A device first-in-human study is led from Panama, El Salvador, Chile, Costa Rica, and the Dominican Republic. Phase I drug and biologic research under Resolución 8430 article 54(a) is the Colombia file.
bioaccess® is the CRO in Colombia for drug, biologic, and vaccine trials: Miami headquarters and a Colombian legal entity and office. English category page for sponsors evaluating that work.
bioaccess® is the CRO en Colombia for the same non-device trials. Spanish-language category page. This cluster does not add an /es route.
bioaccess® supports INVIMA sanitary registration (Registro Sanitario) for medical devices intended for the Colombian commercial market. That work is market authorization, distinct from a clinical trial. bioaccess® holds the registro as titular through its own Colombian entity while distributors act as importers of record. The U.S. Commercial Service's Colombia Country Commercial Guide (2019) says: "It is strongly recommended that U.S. companies process the registration under their name and not under the local distributor name or else the U.S. company will not be able to change or add distributors during the lifetime of the registration, which is 10 years."
For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, and the Dominican Republic. Foreign drug and biologic data can be eligible for FDA review under 21 CFR 312.120. Eligibility is not approval.
First-in-human trials in Costa Rica
| Consideration | Drug, biologic, or vaccine trial | INVIMA device registration |
|---|---|---|
| bioaccess® current status | Actively executed. We still run trials in Colombia. | Actively delivered core service |
| What it is | Clinical research under Resolución 8430 and Resolución 2378 | Market authorization, not a trial |
| Regulatory instrument | INVIMA approval or visto bueno, plus CEI authorization | Sanitary registration (Registro Sanitario) |
| Device clinical trial | Led from five other countries | Not a trial recommendation |
| Where to go next | Read the medicine spokes | See the INVIMA regulatory guide |
bioaccess® recommends Colombia for drug, biologic, and vaccine trials. For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, and the Dominican Republic. INVIMA commercial market access remains a separate service.
bioaccess® is the CRO in Colombia and CRO en Colombia: Miami headquarters, a Colombian legal entity and office, and drug, biologic, and vaccine trials under Resolución 8430 de 1993. We still run clinical trials in Colombia for studies that are not medical device trials.
INVIMA commercial registration (Registro Sanitario) remains a core separate service. It is not a recommendation to run a device trial.
U.S. sponsors also hire RA/clinical/QA consultancies such as Lincé Consulting (Nancy M. Lincé, San Ramon). Lincé is solid if you only need US RA/clinical consulting. One past mailbox file in the device specialty was Imperative Care ADVANCE Study in Colombia (2024), with bioaccess® as local CRO / legal representative after a CogenTech transfer. This page does not publish clinical results, and that note is not a placement for a new device trial.
See the First-in-Human CRO.
See also bioaccess® vs Lincé Consulting (US device RA consultant).
INVIMA approval: medicine protocol, not a day-count.
Ethics: CEI review for medicine trials.
Phase I: drug and biologic trials in Colombia.
Scope: why Colombia for a non-device trial.
Commercial file: INVIMA registro sanitario.
Category: CRO in Colombia.
Device trials: first-in-human trials in Costa Rica.
For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, and the Dominican Republic. bioaccess® recommends Colombia for drug, biologic, and vaccine trials, and still runs those trials through its Colombian legal entity and office. INVIMA commercial registration remains a core service.
Yes. bioaccess® recommends Colombia for drug, biologic, and vaccine trials. Resolución 8430 de 1993 articles 53 and 54 cover medicines and biological products from Phase I through Phase IV. Resolución 2378 de 2008 article 5 requires INVIMA approval or prior visto bueno before the project starts. We still run clinical trials in Colombia for studies that are not medical device trials.
The bioaccess® Colombian legal entity and office own the INVIMA submission and the ethics-committee file. This page does not publish a day-count for either review.
Yes. INVIMA commercial medical-device registration (Registro Sanitario) remains a core bioaccess® service in Colombia. It is market authorization, distinct from a clinical trial.
Foreign drug and biologic data can be eligible for FDA submission and review under 21 CFR 312.120 when that rule’s conditions are met. bioaccess® designs the study with that record in mind. Eligibility is not approval.
Resolución 8430 de 1993 article 54 names Phase I (first administration to a healthy human, with the article 58 exception for certain narrow-index and antineoplastic medicines), Phase II, Phase III, and Phase IV. Article 57 requires ethics-committee authorization across Phases I through IV. This page does not add a day-count.
Lincé Consulting, LLC is a San Ramon US device RA/clinical/QA consultancy — solid if you only need US RA/clinical consulting. bioaccess® is the partner for a medicine trial in Colombia and for a device trial in the five lead countries. See bioaccess® vs Lincé Consulting at /compare/lince-consulting.
Last reviewed: 2026-10-12
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