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Drug Discovery & Development Technology and Intellectual Property (Patents, Trade Marks, etc.)
He has had the Drug Discovery Department, as part of his role as Director R & D, at Wockhardt Limited, discover several new NCEs during the tenure of this position, which NCEs are more extensively described in a later section…
Process Automation: Process Control, Computer System Validation, Alarm Management, & Modeling
Expert served for several years as a major pharmaceutical company's chief Quality Assurance GMP/GLP computer validation auditor. He chaired the team that developed the company's first policy and guidelines regarding computer validation,- and served for several years as the company's…
Parasitology, Immunology, Microbiology, Bioterror Agents, Grant Writing, Med Writing, Expert Witness
Expert has extensive experience in the preparation and submission of 510(k) documents to the FDA for approval of Class II medical devices. His first work in 510(k) preparation and submission was in 1987 for acceptance of a rapid immunoassay for…
Biomechanics, Human Factors, Accident Reconstruction, Motorcycle Accidents, Brain Injury, Helmets, Motorcycle Helmet, Football Helmets, Slip and Fall
Expert, PhD, CPE is a biomechanics expert and has served as an expert witness for 25+ years, providing nationwide expert testimony in the fields of biomechanics, ergonomics, human factors and auto / motorcycle accident reconstruction. Expert has been court qualified…
Developmental and Reproductive Toxicology Study Design, Data Evaluation, and Report Review
Expert (prefers “Expert”) has acquired knowledge and expertise on birth defects in three ways: 1) teaching university courses on human embryology and on causes and manifestations of birth defects; 2) conducting lab animal research; and 3) extensive technical consulting and…
Biomaterials and Product Development R&D for Orthopedic, Cardiovascular, and Other Implants
Expert has helped assemble, and been lead author on 510(k) and IDE applications to the FDA. This has often included telephone conversations, and occasionally personal visits, with the FDA to discuss unique aspects of the devices and/or materials in the…
Food Product Development: Organic Nutritional Products; Sports Nutrition. Non-Meat Products.
FOOD FORMULATION; FOOD PRODUCT DEVELOPMENT; FOOD PRODUCT PROCESS DEVELOPMENT. Expert has extensive experience in food product development. He performs initial concept literature and patent searches and summarizes the results. He then develops a final marketing or medical concept formulation for…
Biomedical Device Engineering
BIOMEDICAL PRODUCT DEVELOPMENT; MEDICAL DEVICE PRODUCT DEVELOPMENT; NEW PRODUCT DEVELOPMENT. Expert has dedicated his career to the research, design, development, engineering, and manufacturing of biomedical devices and instruments. Expert has directed medical device new product development projects and a product…
Information Management
Expert has had over 30 years of experience in the laboratory environment. Prior to starting his independent consulting practice in 1985, he was employed in industry. He has been actively engaged in the use of computers for the management of…
Uses of Polymers, plastics, silver and other metals. EPA regulatory processes
For the past 25 years, expert has been actively involved in all phases of medical plastics synthesis, processing, and use. His experience includes custom formulation of polymers, analysis of medical markets, and selection of materials that will withstand the various…