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.

Why Choose ProPharma's Team of FDA Expert Witness Consultants? 

Our expert team sets the global standard for FDA-related litigation support. We offer:

Unmatched Regulatory Expertise

Our roster is comprised of more former FDA employees than any other consulting firm—including former reviewers, inspectors, compliance officers, and division directors who understand FDA expectations from the inside out. Our bench also consists of many senior industry executives, with an impressive breadth and depth of scientific and regulatory expertise.

Scientific and Strategic Depth

In addition to regulatory backgrounds, our experts are PhD/MD scientists, clinical trialists, engineers, and manufacturing specialists with deep domain knowledge across the product lifecycle.

Credible, Court Tested Authority

We are the most trusted FDA expert witnesses in the world, with extensive experience supporting clients in federal and state courts, arbitration panels, and regulatory hearings.

Clarity That Persuades

Our consultants translate complex regulatory and scientific concepts into clear, defensible testimony that resonates with judges, juries, and legal counsel alike.

Strategic Support at Every Stage of Litigation

Whether you're building your case or preparing for trial, we serve as a strategic partner throughout the legal process:

  • Early Case Assessment: We help legal teams evaluate regulatory strengths and weaknesses and refine case strategy
  • Expert Reports & Declarations: Our experts craft detailed, objective reports that withstand scrutiny and communicate clearly
  • Deposition & Trial Testimony: Our seasoned experts are skilled at delivering confident, credible testimony that holds up under cross-examination
  • Rebuttal & Opposing Expert Analysis: We review and critique the opinions and assumptions of opposing FDA experts to help you anticipate challenges and build counterpoints

From technical assessments to high-stakes testimony, ProPharma’s expert witness consultants deliver the insight and authority your case needs.

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Who We Serve

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Our FDA expert witness services are trusted by top-tier clients around the world, including:

  • Law Firms representing pharmaceutical, medical device, biotechnology, and diagnostics companies in civil, criminal, and regulatory matters
  • Life Sciences Companies facing litigation, government investigations, product recalls, or shareholder actions
  • Insurance Providers & Risk Managers seeking defensible analysis of regulatory compliance and product safety claims
  • Litigation Support Firms in need of high-caliber expert evaluation, documentation review, and testimony

When regulatory credibility is on the line, leading firms rely on our unparalleled FDA knowledge and litigation support capabilities.

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Partner with the World's Leading FDA Experts

With the largest team of former FDA professionals and globally recognized scientific and regulatory expertise, we are the trusted authority for FDA expert witness support. Our consultants have shaped policy, led inspections, reviewed product submissions, and now help clients succeed in high-stakes litigation.

ProPharma: The World's Leading Regulatory Consultancy

Contact us today to discuss your case and learn how our experts can strengthen your legal strategy with insight that only firsthand FDA experience can provide.

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