FDA Submission Expert in Clinical Trials

Case Description:

An expert in the FDA submission process was requested to evaluate the clinical trial of a transdermal application of an anti-inflammatory drug. The client was a leading global provider of contract and consulting research and development services for 40 of the top 50 pharmaceutical companies in the world. The company was contracted by a pharmaceutical manufacturer to facilitate the FDA approval of a transdermal application (skin patch) of a non-steroidal anti-inflammatory drug.

The research and development company contracted with a third party to facilitate a healthy person test of the patch. During the initial phase of the clinical trial, one volunteer developed an adverse reaction. The reaction was one of the known risks, but it eventually required the attention of a dermatologist. IMS ExpertServices sought an expert in the FDA submission process to review the clinical trial and evaluate the information submitted as part of the FDA approval process.

Experts Presented:

  • Clinical Research

    This expert in the FDA submission process received his BA in Biology and Physics and his Ph.D. in Pharmacology and Environmental Toxicology. He has over 23 years experience in pharmaceutical research and development ranging from the laboratory to the market place. He is a consultant to over 100 pharmaceutical and medical device companies preparing clinical trials, drug development plans, clinical protocols and reports, as well as IND's, IDE's, NDA's, PMA's, and PLA's for worldwide submission. IMS Reference #4367784

  • Drug Development

    This expert in the FDA submission process is a scientist and business executive with 30 years of diversified experience in the chemical, pharmaceutical, and biotechnology industries. He is academically qualified with scientific and business degrees and has been widely published. He has been responsible for numerous NDA, IND, and 510(k) submissions and approvals. He currently consults with the pharmaceutical research industry in areas of quality assurance, regulatory affairs, and new product development. He is very familiar with the Informed Consent requirements and the IRB requirements. IMS Reference #4578036

  • FDA Policies and Practices

    This expert in the FDA submission process is quite knowledgeable in the area of clinical trials and the FDA approval process from his 22 years spent in senior positions with the FDA. Prior to retiring he was Acting Director of the Center for Drug Evaluation and Research. He also participated in the first FDA approval of transdermal applications. IMS Reference #4999556

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Industry: All, Pharmaceuticals