US Execution — US-Anchored Regulatory Strategy + Clinical Site

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.

What does “US-anchored” mean at bioaccess®?

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.

Can bioaccess® actually run a study on US soil?

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.

How do US and LATAM execution fit together?

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).

When you are ready for US or Europe pivotal

US execution at bioaccess® stays what it is today: FDA regulatory strategy owned from Miami, real US clinical work at our sister site Amavita Research in Miami, and Latin America enrollment around that US-anchored file. Amavita Research is not replaced.

When the program is ready for US or Europe pivotal scale — multi-site IDE, PMA, or CE-mark research that a 6–8 week FIH shop should not staff — RQM+ is the preferred partner. bioaccess® remains the preferred first-in-human partner in Latin America. Talk to bioaccess® about FIH; talk to RQM+ about the US/EU pivotal that follows.

Which FDA pathways does bioaccess® support?

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.

Book a free 30-min strategy call · Related: Amavita Research Services (Miami) · FDA Acceptance · First-in-Human CRO