Pharmaceutical

Innovation in the pharmaceutical industry has a widespread impact that ignites competition and drives conflict in one of the most scrutinized areas of life sciences. WIT represents highly credentialed experts who know the pharmaceutical industry and can address issues regarding the research, development, and manufacturing of drugs and medications.

Pharmaceutical companies face constant challenges, including protecting intellectual property and navigating evolving government regulations. Our pharmaceutical expert team is comprised of world-class academics, industry executives, and former government regulators who were carefully selected for their knowledge, experience, and ability to communicate effectively.

Trends

FDA-Regulated Drugs and Devices

WIT represents the most qualified experts for litigation involving the science, manufacturing, and distribution of FDA-regulated drugs, chemical components, and medical devices.

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Up Next: Drug and Vaccine Development

Drug and Vaccine Development

The accelerated pace of drug and vaccine development will create many areas of dispute for pharmaceutical companies. From regulatory enforcement actions to intellectual property litigation, WIT has leading testifying experts in relevant fields.

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Up Next: FDA-Regulated Drugs and Devices

Our Experts

Our focus on the pharmaceutical industry allows us to bring together independent testifying experts under one virtual roof to address issues in complex legal disputes involving:

Small Molecule/Synthesized Drugs
Biologic and Biosimilar Drugs
Over-the-Counter (OTC) Drugs
Research and Development
Clinical Trial Design, Monitoring, and Data Analysis

Manufacturing Processes, CMC, cGMP, and FDA Compliance
Marketing, Labeling, Advertising, and Off-Label Promotion
Sales, Distribution, Pricing, and Anti-Kickback Regulations
Drug Diversion and Counterfeit Operations

Related Insights

Case Study- Life Sciences

Case Study: Experienced Urologist Needed for ANDA IP Infringement Dispute

The defendant approached WIT to provide an expert who could help bring their drug to market and invalidate the claims of the plaintiff. This case called for an expert who possessed a deep understanding of renal cell carcinoma (kidney cancer). Let’s see how WIT was able to meet the ask.

Press Release

WIT Legal Releases New Report on 2023 Activities and Trends in Hatch-Waxman Litigation

The report examines Abbreviated New Drug Application (ANDA) cases and the Orange Book-listed products at issue.

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What are some of our other areas of focus in Life Sciences?

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