DABFE - Diplomate American College of Forensic Examiners, CNS - Certified Nutrition Specialist, ERT - European Registered Toxicologist
PhD (1983) - Cornell University - Nutritional Toxicology and Preventive Medicine MS - (1981) - Cornell University - Human Nutrition/Toxicology BS - (1978) - Cornell University - Animal Science/Reproduction
Biologics/Biotherapeutics/Biotechnology, Chemical Warfare Agents, Consumer Products, Dermal Toxicology, Dietary Supplements, Drug/Pharmaceutical Development, GLP Study Auditing, Hematologic Toxicology, Immunotoxicology, Medical Devices, Medical/Clinical Toxicology, Metals Toxicology, Over-The Counter Products, Pharmacokinetics/Toxicokinetics, Product Safety Assessment, Regulatory Toxicology, Risk Assessment, Safety Pharmacology, Statistical Evaluation, Toxicologic Pathology
Dr. McLain's areas of expertise include nutritional toxicology, preventive medicine, immunotoxicology, medical device development, and statistical design of experiments to maximize their predictive power. He has consulted for the Department of Defense, non-profits, large pharma, and smaller biologics/biotechnology companies. He has considerable experience in regulatory document preparation, beginning with the preIND meeting and concluding with the IND/IDE/CTA/CTD/510(k) submission.
Dr. McLain has more than 30 years experience in pharmaceutical (including nutritional), biologics, and medical device development, including combination products. He is the current convener for ISO TC194/WG7 (systemic toxicity evaluation) and has both worked and lived abroad, providing him with a firm grasp of the requirements for international submissions. He has represented clients worldwide to these various regulatory bodies.
7565 Heather Knoll Lane
Sauk Prairie Estates