FDA Regulatory Expert in Stability Protocol

Case Description:

Our client requested an FDA regulatory protocol expert witness search to address stability protocol issues of the clients’ anti-hypertensive medication in a patent litigation case. This patent litigation case, involving a solid dosage anti-hypertensive drug, addressed how to assess stability and, more specifically, FDA regulatory protocols for demonstrating that stability factor to the FDA.

IMS ExpertServices sought a consultant with familiarity of the FDA regulatory process who had worked with or consulted for the FDA on solid dosage stability protocols as they relate to scaling up dosages. This expert would work as a litigation consultant to prepare reports and as an expert witness to educate the judge at trial.

Experts Presented:

  • Pharmaceutical Chemistry

    This FDA Regulatory expert has more than 20 years experience in pharmaceutical chemistry. His specialty is research and development and commercial processing of new products. He is currently Chief Operating Officer of a consulting and contract Research and Development firm. His experience has included solid dosage products, relative stabilities, pre-formulation and formulation studies. His prior experience includes R&D Advisor with a large pharmaceutical manufacturer where he improved bulk drug processes, plant scale-up and manufacturing improvements. He is deeply familiar with FDA regulatory protocols and drug delivery systems including multi-ingredients and coatings. IMS Reference #4982381

  • Analytical Chemistry

    This FDA regulatory expert is an analytical chemist with more than 15 years experience in pharmaceutical research and investigation. He is an adjunct professor with a major university and a consultant in the pharmaceutical industry. One of his research specialties is testing procedures for pharmaceutical solids. He is widely published and has frequently presented on the topic of pharmaceutical composition and stability. He received his Ph.D. in Physical Chemistry and his B.S. in Chemistry. IMS Reference #4983957

  • Analytical Chemistry

    This FDA regulatory protocol expert has more than 30 years experience as an analytical chemist. While working with a pharmaceutical research and development company his responsibilities included establishing and directing the testing and analytical sites and labs. He directed the analytical aspects of solid dosage stability studies, methods and submissions to the FDA. This expert has had articles published on topics such as Solid Dosage-form analysis. He has also spoken on topics such as Analysis of Controlled Release Products and Method Validation for Impurities and Stability. IMS Reference #4983961

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Industry: All, Pharmaceuticals