Regulatory Affairs
Our Regulatory Affairs (RA) team and group of consultants 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 20+ years of solid experience in the medical device industry in the areas of regulatory and quality affairs producing original IDE, PMA and 510K submissions as well as broad international exposure (Europe, Canada and Asia). We maintain an excellent relationship with the FDA and our global experience enables our clients to deploy their clinical trials worldwide.
Ideally, RA becomes involved during the research and development phase and FDA pre-meetings, rapidly moving into clinical trial protocol submissions and extending through trial management, premarket approvals, manufacturing, labeling, advertising, and post-market surveillance.
If you would like to know more about our teams’ capabilities or have a project you would like to discuss please call 845 278 0576 or email us.