Our promise is for foreign medical device companies that believe that Latin America offers untapped potential to conduct trials and sell their products. We focus on forward-looking medical device companies that want to run a first-in-man clinical trial and want to have long-term sales growth in the region. We promise that by engaging with us as your CRO, regulatory, or market access consultants, your company will cost-effectively get the clinical data it needs or will be able to increase its sales in Colombia and the rest of Latin America.
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 people market with universal healthcare.
With a 30-day regulatory MoH approval for first-in-man 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 an expert clinical research, regulatory and market access team. It includes members with over 20 years of proven experience in Latin America. They have processed and approved hundreds of regulatory dossier files for clinical trials and product registrations, and have worked for global life science companies to conduct market research and create winning market access plans.