Foreign medical device companies struggle to find a cost-effective clinical trial site or to gain market share in Latin America. They are unfamiliar with Latin America and lack in-house experts who can operationalize a successful clinical research, regulatory, or market access strategy in Colombia.
bioaccess.™ is a US-based contract research organization (CRO), regulatory, and market access consulting company that delivers a full spectrum of offerings from bench to commercialization so that foreign medical device companies can have long-term success in Colombia and the rest of Latin America.
Imagine if you could conduct your clinical trial, and sell your medical device in a large 50-million market with universal healthcare.
With a 30-day regulatory MoH approval for medical device trials.
With OECD membership that ensures alignment of its legislation, policies and practices to global first-world standards.
With a free-trade agreement with the US, the EU, and the Pacific Alliance (a developing single economic and regulatory market for Mexico, Peru, Chile, and Colombia).
bioaccess.™ has a regulatory team based in Colombia and includes members with over 20 years of proven experience. They have processed and approved hundreds of regulatory dossier files for clinical trials and product registrations.