Key takeaways. bioaccess® is not a generic US-based CRO. We anchor first-in-human (FIH) programs in the United States — FDA Pre-Sub, IDE, and IND regulatory strategy owned out of our Miami, FL headquarters in U.S. business hours — and we execute real US clinical studies through our sister organization Amavita Research Services LLC, a dedicated clinical research site in Miami, FL for medical-device and early-feasibility studies. This complements our Latin American FIH execution so sponsors can run US-anchored programs with FDA-submissible data.
US anchoring means the regulatory strategy and sponsor relationship are owned end-to-end from our Miami, FL headquarters. A U.S.-based project lead runs your program in Eastern Time, owns the FDA submission pathway (Pre-Sub / Q-Sub, IDE, IND, 510(k), De Novo, PMA, HDE), and attends FDA meetings alongside your regulatory counsel.
Yes. Our sister organization Amavita Research Services LLC operates a dedicated clinical research site in Miami, FL focused on medical-device and early-feasibility studies. That gives sponsors a real US execution option that pairs with our Latin American FIH sites.
Sponsors typically anchor regulatory strategy in the US, run US-based patients through Amavita in Miami where appropriate, and concentrate the balance of enrollment across our lead Latin American FIH execution jurisdictions (Panama, El Salvador, Chile, and the Dominican Republic) to hit a 6–8 week study start. Data flows into a single FDA submission under 21 CFR 812.28 (devices) and 21 CFR 312.120 (drugs).
FDA Pre-Submission / Q-Submission, IDE, IND, 510(k), De Novo, PMA, and HDE. See First-in-Human CRO for the pillar overview and FDA Acceptance of Foreign Clinical Data for the bridging mechanics.
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