Safety Pharmacology, Pharmacology & Toxicology. Preclinical pharmaceutical development strategy and planning for conventional pharmaceuticals, biotechnology products, biologics, nutraceuticals, dietary supplements and medical devices. Program & study monitoring. Regulatory document preparation and review. Expert reports. Design and management of drug discovery screening and lead optimization programs. Technical & GLP training. Facility and program auditing. USDA & AAALAC Inspection preparation inspections. Animal rights situation management. Mycotoxins and mycotoxicoses. Litigation support.
Experience
Thirty-six years in biomedical research composed of fifteen years as a senior level scientist at a major pharma company, eight years teaching courses at a major university in toxicology and veterinary medicine, and thirteen years designing IND, NDA, PLA, 510(k) and PMA programs along with directing the science and overseeing the conduct of studies at a well-respected mid-size CRO. Seventeen total years in toxicology consulting. Background encompasses wide variety of therapeutic classes of compounds and indications. Regulatory experience.
