Many life science disputes and investigations require more than general industry experience. They require experts who understand how regulated companies are expected to operate in the real world and who can evaluate whether the facts align with FDA requirements, quality system expectations, and established industry practice.
The FDA Group supports legal counsel, insurers, manufacturers, sponsors, and other parties with expert witness services in matters involving product quality, compliance, regulatory decision-making, inspections, and operational performance in FDA-regulated environments.
Review of quality, regulatory, clinical, and manufacturing records
Analysis of compliance against applicable FDA regulations and industry standards
Expert reports and rebuttal reports
Deposition preparation and testimony
Deposition preparation and testimony
Trial and arbitration support
Trial and arbitration support
Case assessment and technical issue identification
Interpretation of inspection findings, warning letters, CAPAs, deviations, and remediation activities
We provide access to expert witnesses and consulting experts with backgrounds that may include, but is not limited to:
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.
