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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…
Pharmaceutical Research and Product Development, Formulation and Analysis
Expert has spent nearly 25 years at Employer, teaching undergraduate and graduate courses in controlled drug delivery systems, pharmaceutical solutions, drug stability, drug diffusion and pharmaceutical rate processes. Before coming to USP, he was a teaching assistant at University of…
Biotechnology Product Reviews, Biologics, Drugs & Medical Devices, FDA Litigation, Vaccines, etc.
Over 18 years experience with legal, scientific, business and regulatory issues affecting the research, development and commercialization of biomedical and information security products. Recognized expertise in strategy development, audit and due diligence, outsourcing, and FDA regulatory matters, including consulting for…
Gene Expression, Genomics, Microarrays, DNA, Drug Discovery, Product Development
Expert has worked in the biotechnology industry for more than 30 years. He has directed R&D efforts in gene expression technology, genetic engineering technology, DNA microarrays, and high-throughput screening at Sandoz (Novartis), Operon, Agraquest, and GenoSpectra. He has led product…
Aseptic Process Design, Airflow Visualization, HACCP, PAI Preparation, Cleaning Validation
Expert has performed validation of aseptic processes including technologies such as blow-fill-seal, high-speed automated liquid and powder filling lines, lyophilization, barrier and isolation technology, and bulk pharmaceutical and biological processes. Expert has developed an airflow visualization procedure to assist the…
Pharmaceutical Product Development, Drug & Medical Device Safety, Regulatory Affairs
Expert is active in U.K. General Practice with wide therapeutic area knowledge and practical patient prescribing. He has a good understanding of the U.K. health system, formulary adoption, N.I.C.E., and reimbursement. Expert has 15 years of experience in the design,…
Facilitating Business Growth Through Commercialization of New Medical and Biotechnology Products
Expert has extensive experience supporting clients in pharmaceutical, medical and industrial markets. An electrical engineer by training, and the principal of his own consultancy for more than 12 years, he brings strong market, business development and technical skills to his…
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…
Veterinary Drugs, Veterinary Pharmaceuticals, Animal Drugs, Animal Pharmaceuticals
Expert retired in 1992 from the FDA after a 29-year career. He spent his career in the FDA as a field laboratory analytical Chemist, a scientific coordinator in the management of Quality Assurance programs for field scientists, a program analyst,…
Health Conditions for International Trade in Fisheries Products, Food Safety, and EU Fisheries
Expert has worked in the Instituto Nacional de Pesca of Ecuador, developing industry codes of practice for processing and handling of farmed and wild-caught shrimp and shrimp products. Assisted with the design and implementation of export certification activities of $450…