FDA Marketing Compliance Expert

Case Description:

An FDA marketing compliance expert was needed for a case involving allegations of pharmaceutical product mislabeling and failure to meet FDA regulations and requirements in connection with the selling and marketing of a leading multi-specialty healthcare company's widely-popular pharmaceutical product.

IMS ExpertServices was asked to locate an FDA marketing compliance expert with knowledge of FDA pharmaceutical regulations and requirements for marketing, advertising and labeling of prescription drugs. This expert was required to have working experience regarding FDA guidelines and the process through which prescription drugs are approved by the FDA.

Experts Presented:

  • FDA Marketing Compliance Expert

    With extensive experience in FDA regulatory compliance and consulting, this expert served as president of a consulting firm specializing in assisting its clients with all aspects of preparation for pharmaceutical marketing and promotion of products with regard to FDA guidelines. Prior to regulatory compliance consulting, this expert served at the FDA for several years in the division of drug marketing, advertising and communications. He also served at the FDA in a directorial and supervisory role, and holds past experience as a litigation attorney for the U.S. Federal Trade Commission (FTC), as an examiner at the U.S. Patent and Trademark Office (USPTO), and as a pharmaceutical chemist. This expert holds both a B.S. in pharmacy and J.D. IMS Reference # 4561283.

  • Pharmaceutical Marketing Compliance Expert

    This expert had extensive experience leading regulatory affairs and advising senior management on regulatory strategies for drug development and facilitating FDA and company interactions. Her past experience includes directing and supervising regulatory review officers at the FDA, in evaluation of advertising and promotional materials for pharmaceutical products. She served as president and owner of a consulting firm specializing in regulatory affairs and compliance for the biopharmaceutical industry. Prior to forming her own consulting firm, this expert held various leadership positions with regulatory consulting firms serving the pharmaceutical industry. She holds a B.S. in biology and Doctor of Pharmacy (Pharm.D.). IMS Reference # 5097289

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