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Analytical Science: Elastomers, Plastics, Pharmaceutical, Medical Devices, and Transformer Oil
Expert has worked the field of analytical chemistry for over 30 years. His PhD thesis was on phosphorus NMR as a trace analytical tool. He joined Goodyear and both developed analytical methods mainly using HPLC and GC and after 6…
Toxicology, Environmental Health and Safety, OSHA Regulatory, Mold, Healthcare and Laboratory Safety
Expert's experience is very broad in the areas of chemicals effects on humans and environmental systems. He has performed academic research on the effects of hazardous chemicals on the lungs, as well as carcinogenic effects of chemicals and air pollutants,…
SARS-CoV-2 Coronavirus, COVID-19, Sanitization Procedures, Forensic Science, Toxicology, DNA Analysis, Food Poisoning, and Toxic Torts
Expert is a Full Professor of Toxicology and has received grants from NIH in the area of Applied Toxicology. Expert has received grants from NIH in the area of Biotoxicology. Part of his research entails molecular analysis of toxins. Expert…
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,…
Medical Pharmacology and Toxicology
Expert is a medical-legal consultant who specializes in cases that relate to drugs and drug pharmacology/toxicology. He has over 20 years of experience. Expert has experience in civil, criminal & administrative cases--both plaintiff and defense. Expert has been certified as…
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…
PK/PD Modeling and Simulation; Nonclinical and Preclinical Statistics; Experimental Design
He managed group of 5 biostatisticians working on Phase I and PK/PD trials. His responsibilities included protocol design, statistical analysis plan writing, specification writing, and delivery of product to customers. He was responsible for meeting all timelines and budgets, assuring…
Medical Packaging: Project Management, Design, Validation, Equipment
Expert is a certified packaging professional with over 20 years experience providing packaging engineering services to the biotechnology and medical device industries. These services include package and labeling development, packaging equipment selection and validation, and package materials and systems performance…
Virology, Drug Discovery, Diagnostics, Bioterrorism, and Vaccines
Expert (, pronounced "Berr-oo-in") has spent over 20 years in the pharmaceutical and diagnostics industries. During that time he has been involved primarily in viral vaccine and antiviral drug discovery, although he has also run general molecular biology groups primarily…
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…