Regulatory Toxicology, Pharmaceuticals, Medical Devices, Foods, Chemicals; Safety and Risk Assessments; Litigation SupportPreclinical development and safety assessments for pharmaceuticals, medical devices, industrial chemicals, personal care and household products, foods and food additives, dietary supplements and cosmetics; CRO selection and monitoring including study design, protocol preparation, report writing and review; preparation of regulatory documents; hazard and risk assessments; litigation strategy and support, patents, workman's compensation and personal injury.
Experience
More than 20 years with major international diversified chemical and consumer product companies in toxicology research, management and consulting positions; served on national and international toxicology committees and panels; expert witness in litigation; authored 30 papers, book chapter; prepared INDs, CTD, 510(k), clinical protocols and investigator's brochures, CRFs
