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Product Development, Product Safety, Regulatory Compliance, Claims Support, Litigation Support
This expert has training and experience in the following areas: Safety of foods, cosmetics and their ingredients; and medical devices, pharmaceutical actives and excipients. Regulatory affairs related to foods, cosmetics, and medical devices. Product development of foods and cosmetics. Management…
Psychopharmacology in Historical Perspective, Regulatory Behavior, etc.
Over the past 20 years he has done extensive research on the history of drug discovery, drug development, drug registration, and the use of psychopharmaceuticals in medical practice. Among the documents he has collected are the virtually complete set of…
Skin Care, Body Lotions, Hair Care, Cosmetics Product Development, Formulation and Marketing
Expert's broad background in personal care product development and marketing includes 15+ years of experience developing and marketing the following types of products: skin care, hair care, bath and body, sun care, soaps, candles, and cosmetics as follows: lipstick, eye…
Marketing and Product Development of Raw Materials for the Cosmetics Market
30 years of experience working in the cosmetics industry as a raw material supplier. Long time member of the Society of Cosmetics Chemists. Developed and marketed new hydrophilic polymers for the cosmetics industry while working for BF Goodrich as the…
Patent Law, Law, Medical Device Design, Drug & Perishable Material Stability, 510(k) Approvals
Expert's legal practice focuses on intellectual property and patents. He is registered to practice both in California for general legal issues, and nationally for patent issues through the USPTO. In addition to filing and prosecuting patents, he also has experience…
Personal Care, Active Ingredient Selection for Product Development, Write Protocols for Testing
Expert has over 25 years of experience with cosmetic products. She can provide information on new ingredients and efficacy for the personal care products. She can advise on the claims, efficacy of the current ingredients in cosmetics and personal care…
Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms
As Vice President at a pharmaceutical company, Expert formulated eight pharmaceuticals for use in their patented buccal delivery platform technology. Five formulations were acceptable to FDA and were allowed to proceed into human clinical trials under IND controls. Four of…
Pharmacoepidemiology, Pharmacoeconomics, Epidemiology, FDA, Drugs, Education
Expert is one of the leaders in the field of pharmacoepidemiology. He has extensive experience consulting on issues of applying epidemiological principles to the risk/benefit assessment of drugs. As Director of Global Pharmacoepidemiology and Health Economics Research for a major…
Physical Chemistry of Food & Drugs
FOOD CHEMISTRY; FOOD DRYING. Expert is a recognized authority in the physical chemistry of the stability of dry and semi-moist systems including foods, drugs, and biologies. His major research areas deal with the effect of temperature and are properties of…
Medical Technology
A significant portion of Expert's current activities include maintaining awareness and working knowledge of regulations that impact medical device manufacturers. She has specific experience with new medical device submissions, including combination products. Expert is proficient in total quality systems requirements…