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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.

Contacts

Our team stands apart from the competition in the following ways:

  • Broad client base: Our lawyers handle compliance and enforcement matters for a diverse range of clients — from Fortune 100 pharmaceutical companies to mid-sized medical device companies to innovator, development stage companies. Along with the diversity of clients comes significant experience with a broad range of products, including vaccines, gene therapies, OTC drugs, APIs, dietary supplements, antibiotics, diagnostic devices, and many others.
  • A powerful footprint: Sidley’s global platform allows us to assist our clients with their product development, research, and manufacturing compliance and enforcement challenges worldwide. We have worked on matters in more than 25 countries, including the United States, India, China, Australia, Japan, Mexico, Canada, and most European Union countries.
  • Government agency insight: Over the course of their careers, our lawyers have represented numerous clients before the FDA, HHS, the Department of Justice, and the European Commission. Leveraging our technical experience and strategic insight, we have advocated successfully on behalf of our clients in many investigations and enforcement actions.

Our lawyers are well-versed in the following types of work:

  • Good Manufacturing Practice/manufacturing compliance
  • Global life sciences compliance and enforcement
  • Data integrity
  • False Claims Act – FDA and GMP theories
  • FDA inspections
  • Clinical research fraud investigations
  • GMP recall investigations
  • Risk diagnostics

Our Team

We have a strong track record of success as global advocates in delivering a full range of creative solutions to the challenges our clients face. Our lawyers represent clients before proceedings with government agencies, drawing upon their knowledge of the law developed from working in senior government posts within the FDA, the Department of Justice, and the European Commission.