Clients turn to Reed Smith’s highly regarded FDA attorneys for help in achieving and maintaining compliant operations as they seek to develop and commercialize products and services in a business environment that is evolving on a real-time basis. Our team can counsel clients on traditional FDA-related challenges, such as inspections and investigations, as well as on developing areas, such as personalized medicine and gene therapy, software as a medical device (SaMD), artificial intelligence (AI), and machine learning (ML).

Innovative, future-focused life sciences and health care companies require strategic insights on a wide array of FDA and related regulatory matters to assess opportunities and risks, advocate for solutions that benefit patients or customers, and develop tailored risk mitigation strategies. We are proud to be the trusted advisors of numerous companies in the pharmaceutical, biologic, compounding, medical device, digital health, telehealth, pharmacy, laboratory, animal health, dietary supplement, food, and cosmetic spaces. We also counsel companies providing technology and services targeted to these regulated sectors.

Additionally, we regularly provide tailored regulatory due diligence advice and counseling to life sciences and health companies seeking strategic growth – whether through a range of collaboration agreements, mergers, acquisitions, divestitures, or financing opportunities – as well as to investors and investment banks and financial services companies that are active in the life sciences and health care sectors.

In addition to our knowledge of and focus on these issues at the federal level, we also assist life sciences and health care clients with related matters at the state level, typically involving state boards of pharmacy and health departments.

Our team includes a partner who was formerly a registered nurse; lawyers with advanced degrees in public health, global health, pharmacy, and business administration; and lawyers with backgrounds in science and computer science, giving us a unique perspective into our life sciences and health care clients and their needs.

Additionally and importantly, our team works seamlessly with colleagues around the world to provide our clients with comprehensive services and counseling. For example, we draft specialized manufacturing and quality agreements with our corporate colleagues, collaborate with our international trade colleagues to assist clients with import and export issues, and work with colleagues in Europe and Asia to provide strategic cross border regulatory counsel for clients whose needs require interactions with or advice on FDA’s equivalent organizations around the world.