FDA Expert Witness Services

Leverage The Most Trusted FDA Experts in the World

When litigation hinges on FDA compliance and regulatory interpretation, credibility and clarity are everything. ProPharma's expert witness consulting services deliver unparalleled insight, strategic support, and courtroom-ready testimony from the largest team of former FDA and senior industry professionals in the world. Whether you're involved in a business dispute, product liability case, patent issue, or pursuing damages in a regulatory dispute, we provide expert guidance rooted in real-world FDA experience and scientific rigor.

Comprehensive FDA Expertise Across Product Areas

We support legal teams and life sciences clients in a wide range of matters involving FDA-regulated products, including:

• FDA Enforcement Actions: 483 observations, warning letters, consent decrees, import detentions, and recalls
• Product Development & Approval Pathways: NDAs, ANDAs, 510(k)s, PMAs, De Novo submissions, and combination product strategies
• Pharmaceutical, Biotech & Device Litigation: Adulteration, misbranding, product liability, and regulatory negligence claims
• Advertising & Promotional Compliance: OPDP compliance, off-label promotion, fair balance, and substantiation disputes
• Clinical Trials & GCP Compliance: Site inspections, data integrity, informed consent violations, protocol deviations
• Manufacturing & Quality Systems: cGMP/QSR deficiencies, supplier quality, CAPAs, MDRs, and risk management gaps

Our team of FDA Expert Witness Consultants brings an insider’s perspective to every case—identifying gaps, explaining regulatory expectations, and anticipating FDA interpretations that can sway outcomes.