Donald Schmitt, M.B.A., M.P.H.
Senior Managing Scientist


Phone(630) 352-0303
Address931 W 75th Street
Suite 137, PMB263
Naperville, IL 60565




Professional Profile

Mr. Schmitt has more than 40 years of corporate and consulting experience in toxicology, risk assessment, and regulatory affairs. He has extensive experience in food ingredient safety assessment, food regulatory affairs, and product claims.  In addition, he has broad experience evaluating the safety of additives and contaminants, feed additives, human and veterinary drugs, medical devices, cosmetics, and environmental and occupational exposures during his tenure in the drug and health-care industries. He has developed regulatory strategies for FDA-regulated products in support of regulatory compliance, product defense, product development and claims, and pre-market approval. Mr. Schmitt has conducted pre-clinical toxicity evaluations of drugs, medical devices, and biologics for both the government and private sectors. He has designed, contracted, and monitored pre-clinical safety studies required for regulatory clearance of new food additives, cosmetic ingredients, and human and veterinary drugs for clients. He has provided technical support and assisted in the preparation of a variety of reports and submissions to regulatory authorities, including Generally Recognized as Safe (GRAS) affirmation petitions, food contact notifications (FCNs), new dietary ingredient notifications (NDINs), direct and indirect food additive petitions, health claims petitions, clinical study Investigator Brochures, and Investigational New Drug and New Drug Applications (INDs/NDAs). He has experience in quality assurance programs and conduct of GLP and GCP audits.