Qualified FDA expert witnesses to fit any case.

Interpreting and acting on FDA regulations can be difficult and complex. During the lifecycle of development, your product may require the skills and knowledge of an FDA expert witness who knows these regulations inside and out.

These cases often require qualified experts to determine the safety and efficacy of a product and whether the FDA’s guidelines and regulations were met, making it crucially important to find the right professional for the task at hand.

Headquartered in Westborough, Massachusetts, The FDA Group has more than 405 specialists (65 of whom are former FDA Investigators) across 42 states.

  • Former FDA Investigators
  • Former FDA Officials
  • Former FDA Reviewers
  • Microbiologists & Chemists
  • Regulatory Affairs and Regulatory Submissions
  • Quality Assurance & Quality Systems
  • Safety and Pharmacovigilance
  • Clinical Research
  • Toxicology
  • Pathology
  • Pharmacokinetics
  • Pharmacology
  • Pharmacogenomics
  • Product Development
  • Chemistry, Manufacturing & Controls (CMC)
  • Electronic Common Technical Documents (eCTD)
  • Biostatistics
  • Medical Affairs
  • Research & Development
  • Validation & Qualification

The FDA Group is a global leader in FDA compliance and regulatory knowledge. Our expansive staff of former FDA and industry professionals ensures you'll be paired with the right expert witness for your particular case.

Contact The FDA Group today to learn more about our Expert Witness services.