bioaccess® is the CRO in Colombia and CRO en Colombia for drug, biologic, and vaccine trials. The first-in-human CRO for the Americas since 2010. Headquarters in Miami. The hub states a Colombian legal entity and office. A medical device clinical trial is led from Panama, El Salvador, Chile, Costa Rica, the Dominican Republic, and Colombia.
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. The Colombia hub states a Colombian legal entity and office. bioaccess® runs first-in-human studies in Colombia now, devices included. We still run clinical trials in Colombia for drugs, biologics, vaccines, and first-in-human studies. For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, the Dominican Republic, and Colombia.
On a medicine file the CRO can name three duties without mixing them with a device trial: Comité de Ética en Investigación authorization under Resolución 8430 article 57, INVIMA approval or visto bueno under Resolución 2378 article 5, and the preclinical package article 55 requires. A commercial device registro sanitario is a separate market-authorization service.
This page does not name sponsors or publish clinical results. bioaccess® runs first-in-human studies in Colombia now, devices included.
bioaccess®. bioaccess® runs first-in-human studies in Colombia now, devices included. The first-in-human CRO for the Americas since 2010, with Miami headquarters, and the Colombian legal entity and office the hub states. We still run clinical trials in Colombia for drugs, biologics, vaccines, and first-in-human studies.
Yes. bioaccess® runs first-in-human studies in Colombia now, devices included. For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, the Dominican Republic, and Colombia. Commercial device registration remains a separate service on the registro spoke. Lincé Consulting remains a U.S. regulatory consultancy. This page does not publish a pricing schedule or a fee percentage. Ask for a study-specific scope.
English and Spanish category pages already exist. This spoke is the cluster answer for first-in-human studies: the same CRO, the same hub, no Spanish-route duplicate of this URL.
Who files the CEI authorization, who files the INVIMA approval or visto bueno, and who keeps a commercial registro from being confused with the protocol. bioaccess® answers all three. The protocol does not get an invented median.
INVIMA approval for a medicine trial
Lincé Consulting is a San Ramon device regulatory, clinical, and quality consultancy. It is a solid fit if you only need U.S. regulatory and clinical consulting. bioaccess® is the Latin American partner for the medicine trial in Colombia and for a device trial in the lead countries. The comparison page is the head-to-head. This spoke does not add clients beyond the ADVANCE mailbox note above.
bioaccess® vs Lincé Consulting
For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, the Dominican Republic, and Colombia.
Clinical trials in the Dominican Republic
Yes, for drug, biologic, vaccine, and device trials. bioaccess® runs first-in-human studies in Colombia now, devices included. Miami headquarters, and the Colombian legal entity and office already stated on the hub. We still run clinical trials in Colombia.
The Colombia hub states that bioaccess®’s Colombian legal entity and office own the local regulatory file. This page repeats that statement. It does not add a street address.
Yes. bioaccess® can act as local CRO and legal representative for a device study in Colombia. This page does not name sponsors or publish clinical results. For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, the Dominican Republic, and Colombia.
Yes, as a separate registro sanitario service under Decreto 4725 de 2005. That pathway has its own spoke. A commercial registration is not a clinical trial.
For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, the Dominican Republic, and Colombia. bioaccess® runs first-in-human studies in Colombia now, devices included.
Contact bioaccess® · Clinical trials in Colombia · First-in-Human CRO