Sidley’s Food, Drug, and Medical Device Compliance and Enforcement practice helps pharmaceutical, medical device, dietary supplement, and biotechnology companies navigate complex manufacturing, supply chain, research and development, and post-marketing safety issues.
Law Firm of the Year in FDA Law
2020 U.S. News – Best Lawyers “Best Law Firms” Survey
We combine extensive, substantive regulatory and industry knowledge with the experience to handle a wide range of compliance and enforcement matters, such as counseling, risk diagnostics, internal investigations, regulatory inspection preparation and strategic response to regulatory observations, regulatory enforcement actions, criminal investigations, and civil litigation, including False Claims Act litigation. In particular, our team has unmatched experience in Good Manufacturing Practice (GMP), Quality System Regulation (QSR), and Good Clinical Practice (GCP) matters that have potentially significant business, legal, and reputational implications for our clients.