Drug Research and Development

Cosmetics

Regulatory Pharmacology and Toxicology (Rx, OTC)
FDA, ICH Preparation of INDs,

NDAs Regulatory Strategy

Industry representation at Federal, and State, regulatory agencies

Risk Assessment ( Nationally recognized)

Food Additives

Product Safety

CTD and eCTD (electronic filing)

Opthalmic and Dermatological Products

Carcinogenicity bioasays, assessment, risk (Leading role)

Plastics, Safety

Good Laboratory Practice

Litigation and arbitration

Literature search, online and at NIH and NLM

Animal Drugs