Kevin Madagan

Kevin Madagan specializes in corporate and regulatory matters affecting life science companies, investors, and service providers within the biotechnology, pharmaceutical, and medical device industries. His clients range from pre-clinical and clinical sponsors, drug and device manufacturers, and biotech innovators, to service providers more broadly, such as CROs, CMOs, CDMOs, wholesale and private-label distributors, carriers, clinical laboratories, 3PLs, and pharmacies (ranging from 503A and 503B to specialty infusion and radiopharmacy operations).

Kevin also routinely serves as a trusted counselor to strategic owners, private equity funds, underwriters, lenders, and public and private companies investing in the life sciences industry and advises across the lifecycle of FDA regulated products – whether drugs, biologics (including biosimilars and regenerative therapies, such as cell and gene therapies), medical devices, or dietary supplements and nutraceuticals. Kevin provides sophisticated guidance on supply chain logistics and ancillary service operations; product development and commercialization; regulatory compliance and enforcement; and maintains a specialty practice focused on all facets of the radiopharmaceutical industry, including theranostics.

With a pragmatic yet detailed approach, Kevin takes pride in providing high value legal and strategic insights to ensure clients achieve their business objectives while adhering to the highest standards of compliance.