Regulatory Affairs

ProSciento’s therapeutic-specific scientific and regulatory expertise provides a distinct advantage in navigating the evolving global regulatory environment. Our Regulatory Affairs services typically begin with assessing IND readiness, analyzing regulatory options, and researching marketing opportunities afforded by each regulatory path, with a keen focus on evaluating where the product best fits into the standards of care for metabolic disease and what is needed from clinical and regulatory perspectives to achieve this goal. ProSciento’s Regulatory Affairs Team then provides project management for all document creation, submission, and representation of the client at meetings with FDA and EMA regulatory agencies.

Our regulatory track record speaks for itself with contributions to 17 approved metabolic drugs and devices and more than 100 submissions to the FDA’s Metabolism and Endocrinology Products (DMEP) and Gastroenterology and Inborn Errors Products (DGIEP) Divisions.