Regulatory Strategy Development and Execution for a Medical Device

The regulatory group within a large international pharmaceutical company was developing a new dosing medical device and needed a consultant to guide the team on design control and regulatory approval. Business Talent Group (BTG) deployed a consultant with a 20+ year track record in conception, development, regulatory approval, and commercialization of pharmaceutical products and medical devices. Deliverables included user requirement specification, identification of potential devices, screening and qualification testing, and submission of regulatory filing.