Innovation in the pharmaceutical industry continues to reshape how drugs and biologics are discovered, developed, and manufactured, creating scientific and regulatory issues that often surface in complex litigation. As companies navigate questions around intellectual property, clinical evidence, safety, and compliance, legal teams increasingly rely on our pharmaceutical expert witnesses to clearly explain the science and decision-making behind these products.
DOAR represents life science experts whose experience spans pharmacology, clinical development, manufacturing, and post-market safety. They are familiar with each stage of the product lifecycle—from early research and formulation through clinical trials, regulatory submissions, scale-up, and commercialization—allowing them to address matters involving product design, labeling, risk evaluation, and market performance.
In high-stakes disputes, our testifying experts evaluate the scientific and regulatory record, test competing narratives, and present complex pharmaceutical issues in a way that judges, juries, and regulators can understand and rely on.
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We represent pharmaceutical expert witnesses who are world-class academics, industry executives, and former government regulators who were carefully selected for their knowledge, experience, and ability to communicate effectively.
Expertise in trial design, data analysis, and interpretation of clinical evidence used to support safety, efficacy, and regulatory decisions.
Experience evaluating safety signals, diversion risks, and counterfeit detection, including how quality and surveillance processes address product integrity.
Knowledge spanning biologics, small-molecule drugs, and OTC products, including differences in formulation, manufacturing, and regulatory pathways.
Insight into market dynamics, competitive trends, and regulatory developments that shape product strategy and commercial outcomes.
Background in patent disputes, exclusivity issues, and regulatory adherence across drug development, approval, and post-market obligations.
Experience with cGMP standards, FDA inspections, and production quality systems that affect regulatory status, recalls, and related disputes.
Understanding of labeling requirements, promotional practices, pricing strategies, and how these factors influence compliance and litigation risk.
Our latest Hatch-Waxman report provides a comprehensive look at 2025’s activities and trends in ANDA litigation.
Across 192 biologics PTAB proceedings, a small group of APJs and repeat innovator and biosimilar companies accounts for much of the activity.
DOAR provided a pharmaceutical formulation expert with deep experience in injectable drugs and scale-up processes.
Our latest Hatch-Waxman report provides a comprehensive look at 2024’s activities and trends in ANDA litigation.
We examined Judge Michael Shipp's activity at the United States District Court for the District of New Jersey.
DOAR anticipates future litigation trends in emerging areas of life sciences and builds diverse teams of testifying experts who can best advise our clients.
We asked DOAR biotechnology expert and accomplished academic, Dr. Brenda Wilson, to evaluate the industry with respect to ongoing trends.
DOAR was retained to provide two pharmaceutical experts with expertise in drug composition, albumin-paclitaxel binding, and nanoparticle delivery.