Dr. McLain's areas of expertise include nutritional toxicology, 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.
Experience
Dr. McLain has more than 20 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 worlwide to these various regulatory bodies.
