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Statistical Consulting, Biostatistics, Statistical Support to Litigation
Expert has over 13 years experience as statistician and Director of Biometrics in the pharmaceutical industry. In addition, he has 8 years experience as a Professor of Statistics at the University of Florida. He served as functional manager for statistics,…
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…
Utilities and Energy Companies
Expert is skilled in high value contract negotiation as a counterparty to major petroleum, chemical and utility firms. He has represented financial firms, real estate managers, power plant developers and transmission providers. He has significant experience on both sides of…
Biomaterials: Biocompatibility, Pathology, Devices
Expert J. Expert is a D.V.M. with a Ph.D. in veterinary pathology. He is also board certified by the American College of Veterinary Pathologists. As part of his Ph.D. research training he was involved in the characterization of several spontaneous…
Environmental Management, Experimental Designs, Refinery Processes
Expert C. Expert discovered and patented methods and catalysts for reducing SOx emissions from fluid catalytic cracking (FCC) operations. He designed and constructed testing equipment for fast turnaround and low cost screening of SOx catalysts. He has investigated refinery NOx…
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…
Radio Communication Engineering and RFID, Patent Searching & Evaluation, FM Communication, HF, VHF
Expert has been a licensed radio amateur since 1969 and has used his amateur radio experience and background to establish training and fundamental radio development skills for students in radio communication technology. Expert uses amateur radio antenna fundamentals and experiments…
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…
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…
Adhesive Consulting, Formulating, & Research in Structural, PSA, Hot Melt, Epoxy, Urethane, & Wood
Expert D. Expert has done adhesive failure analysis projects in connection with establishing cause in litigation cases or in research and production problems. For example, a wood millwork manufacturer claimed an adhesive was faulty, resulting in customer loss and damages.…