Expert Witness

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. 

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FDA Expert Witness Services

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.

We provide expert witnesses with the following backgrounds and areas of expertise:

  • Former FDA Investigators
  • Former FDA Officials
  • Former FDA Reviewers
  • Former Executive Health Officer
  • 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

Qualified state public health expert witnesses to fit any case

In addition to having former FDA officials who regularly serve as knowledgeable expert witnesses in federal cases, The FDA Group’s large staff of specialists also includes former heads of public health departments.

These experienced professionals offer decades of experience in a variety of state public health programs as well as compliance with state regulations, and much more. Click here to view the CV of an Executive Health Officer who has testified in over a dozen cases representing public health jurisdictions.

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

Brochure Learn more about The FDA Group.

Read our brochure to learn more about our full range of life science resourcing capabilities.

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Contact us today to learn more about our expert witness services.