bioaccess.™ is a US-based contract research organization (CRO), regulatory, and market access consulting company that delivers a full spectrum of services from bench to commercialization so that foreign medical device companies can have long-term success in Colombia and the rest of Latin America.
Our promise is for foreign medical device companies that believe that Latin America offers untapped potential to conduct trials or sell their products. We focus on forward-looking medical device companies that want to run a first-in-human clinical trial or 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.
Imagine if you could conduct your medical device first-in-human clinical trial and sell your product in a 50-million-people country with 95% of its population covered by universal healthcare.
With a 30-day MoH regulatory approval for first-in-human trials, and very short marketing approval for commercial devices.
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 and the EU.
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.