Name
Daniel McLain
Educational Degrees
MS, PhD
Certifications
DABFE - Diplomate American College of Forensic Examiners, CNS - Certified Nutrition Specialist, ERT - European Registered Toxicologist
Education
PhD (1983) - Cornell University - Nutritional Toxicology and Preventive Medicine MS - (1981) - Cornell University - Human Nutrition/Toxicology BS - (1978) - Cornell University - Animal Science/Reproduction
Expertise
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
Specialties
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.
Experience
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.
Address
7565 Heather Knoll Lane
Address 2
Sauk Prairie Estates
City
Verona
State
WI
Zip Code
53593
Country
USA
Telephone
608-827-5066
Fax
608-827-5066
Mobile Number
608-215-6385