Litigation Support

FDA Regulatory Counsel supports litigation involving FDA-regulated products and companies by adding insight on complex FDA issues. We provide subject matter expertise in product liability cases across the country and are practiced in navigating DOJ enforcement actions.


Representative Matters

  • Apply regulatory insight to global issues of fact and law

  • Advise on and conduct compliance-related discovery, including drafting interrogatories, taking depositions, and interpreting information and documents.

  • Support expert witness testimony.

  • Inform motions practice and trial proceedings on FDA-related issues.