We are pleased to announce that Mr. Donald F. Schmitt has joined ToxStrategies, Inc. as a Senior Managing Scientist and will be based in the Chicago area. Mr. Schmitt has 30 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, 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. Additionally, 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/notifications, food contact notifications (FCNs), new dietary ingredient notification (NDIs), direct and indirect food additive petitions, health claims petitions, clinical study Investigator Brochures, and Investigational New Drug and New Drug Applications (INDs/ NDAs).
To read more about Mr. Don Schmitt and get his contact information, please visit his company web page.