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Pharmaceutical Science; Preformulating, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation
As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for…
Pharmaceutical Development
Expert is a former FDA Review Chemist, with > 39 years of career experience in pharmaceutical R&D, Quality Operations and Regulatory Affairs. For 25+ years as a consultant in his own pharmaceutical development advisory firm, Expert has furnished clients with…
Personal Care and Household Products
Expert has experience in the formulation, manufacturing, and marketing of the listed household products (among others) to the retail industry. He has experience and knowlege in manufacturing and U S Food and Drug Agency regulations. He also possesses experience in…
Cosmetics, Packaged OTC Drugs, Nutraceuticals, Design, Processing, Quality Issues
Expert has fifty years of actual bench experience doing laboratory and pilot development of the listed areas of expertise. Expert has visited the FDA over 100 times in support of various submissions. Expert has worked for several contract manufactures of…
Gynecology, Urogynecology, Family Planning
Expert is Professor of Gynecology, Urogynecology, and Family Planning at Baylor College of Medicine with nearly 35 years of clinical, academic, and research experience. He is also Medical Director of a regional Planned Parenthood for the past 25 years. He…