Our drugs, biologics, and medical devices team has inside-FDA experience and in-depth scientific knowledge of drugs, biologics, medical devices, and combination products, as well as cutting-edge biosimilars and regenerative therapies. We represent innovators ranging from early-stage startups to several of the largest biopharmaceutical companies in the world.

Because intellectual property is the most important asset of many medical product companies, our FDA regulatory practice is fully integrated with our top-10 ranked patent practice of more than 100 IP attorneys. We use this experience to obtain the best possible results for clients facing exclusivity, life-cycle management, patent extension, product classification, and similar issues before FDA. Our patent attorneys not only understand FDA, some worked at FDA before joining the firm.

We also offer non-legal regulatory affairs services for clients who need scientific instead of legal advice. Our regulatory affairs division advises clients on product development and clinical issues, as well as representing them at regulatory meetings and in preparing submissions to FDA for drugs, biologics, and medical devices. In addition to our regulatory affairs staff, we employ over 80 scientific and medical professional including MDs, PhDs, Masters-level researchers, and nurses, who provide scientific support on a wide range of issues.