Regulatory Affairs
Ideally, regulatory affairs become involved during the research and development phase with FDA pre-meetings, moving into clinical trial protocol submissions and extending through trial management, premarket approvals, manufacturing, labeling, advertising, and post-market surveillance.
Our regulatory affairs team have a long and varied experience in industry, government and academia and excel in the areas of technical writing, regulatory negotiations and strategic planning. We possess 15+ years of solid experience in the medical device industry in the areas of regulatory and quality affairs producing original IDE, PMA and 510K submissions. We maintain an excellent relationship with the FDA and our broad experience enables our clients to rapidly deploy and complete their clinical trials.