Expert in FDA Regulations, Drugs, Cosmetics

Available for your Consulting and Expert Witness Needs

SUNSCREENS; NEW DRUG APPLICATION. Expert has been intricately involved with the area of sunscreens, and has consulted in areas of regulation, development of new drug applications, label and advertising review, testing, publications, packaging, and patents.

SKIN CARE PRODUCT. Expert has led the development of new concepts for skin care products which have become primary formulation types now being marketed. This area has been the primary concentration of his career, and is a major component of his consulting agenda, including label and advertising review, pharmacological effects, presentations to governmental agencies, and publications.

FOOD AND DRUG ADMINISTRATION REGULATIONS. Expert has extensive experience in developing and submitting new drug applications and amendments for OTC and Rx drugs, mainly topical. He has prepared petitions and submissions to the office of OTC drugs, and has reviewed label copy for cosmetics and drugs, both in his industrial career and as a consultant. He has reviewed drug manufacturing plants for adherance to GMP, prepared protocols for clinical and animal studies, and written articles and book chapters on FDA regulations. In addition, he has helped prepare drug master files.

CLINICAL TRIALS. Expert has recent experience as a consultant in preparing clinical protocols, monitoring studies, and preparing reports for new drug phase I, II, and III studies. He also has prepared clinical trials for claim substantiation, drugs, and cosmetics, and summaries for NDAs and OTC submissions.

GOOD MANUFACTURING PRACTICE. Expert has conducted inspections for evaluation of GMP conformance for domestic and foreign drug manufacturers, and has aided management in plant design and equipment for improved GMP, including reports, SOPs, training guidelines, and procedures.

COSMETICS; DEODORANT. Expert's entire career has involved cosmetics, including new concepts, formulation, testing, advertising copy review, label copy, consumer complaints, and packaging. He has made presentations and written articles and book chapters on deodorants, skin care products and pharmacology, depilatories, and fragrance products. He also has been an expert witness in cases involving hair waving, hand lotions, and waterproof mascara.