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Pharmaceuticals / Regulatory

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Featured Pharmaceuticals / Regulatory Case Studies

Biotechnology Expert in Clinical Trials

A biotechnology expert with knowledge of FDA clinical trials and procedures was requested for an arbitration case involving biotherapeutics.

Drug Protocol Expert in Antiretroviral Therapy Drugs

A drug protocol expert with experience working with antiretroviral therapy drugs was needed for an economic damages case.

FDA Compliance Expert in Pharmaceutical Manufacturing

An FDA compliance expert was sought for a wrongful termination case brought against a pharmaceutical manufacturer.

FDA Marketing Compliance Expert

An FDA marketing compliance expert was needed for a case involving allegations of pharmaceutical product mislabeling and failure to meet FDA regulations and requirements

FDA Regulatory Expert in Stability Protocol

A stability protocol expert was needed to address the protocol issues of the clients’ anti-hypertensive medication in a patent litigation case.

Food and Drug Administration (FDA) Statistical Analysis Expert

A food and drug administration (FDA) statistical analysis expert was needed for a patent dispute that arose in connection with a request for FDA approval for the commercial manufacture, use, and sale of a generic drug.

Healthcare Industry Expert in Pharmaceutical Drug Pricing

A healthcare industry expert with knowledge of pharmaceutical drug pricing practices and how various insurance companies and their differing plans reimburse for drugs was needed for a class action suit.

Pharmaceutical Chemistry Expert in Drug Manufacturing Processes

A pharmaceutical chemistry expert was needed for an intellectual property case involving the drug manufacturing processes of an injectable form of a veterinary medicine.

Pharmaceutical Development Expert with FDA Approval Experience

A pharmaceutical development expert was sought for a misappropriation of trade secrets claim against the Food and Drug Administration.

Pharmaceutical Sales Experts in Drug Labeling and Marketing

A pharmaceutical sales expert was needed to evaluate the marketing claims of competing pharmaceutical manufacturing companies.

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