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Mr. Donald Schmitt is a Managing Scientist in Exponent's Food & Chemicals practice. Mr. Schmitt has nearly 25 years of corporate and consulting experience in toxicology risk assessment and regulatory affairs. He has significant experience in evaluating the safety of foods and food ingredients additives and contaminants feed additives human and veterinary drugs medical devices cosmetics and environmental and occupational exposures. 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 direct and indirect food additive 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. | 