areas of expertise in toxicology and pharmacology
 

Drug, Device, Cosmetics Research and Development

Regulatory Pharmacology and Toxicology

IND, NDA, ANDA, NADA, 510(k), IDE, PMA

Biocompatibility (ISO-10993/FDA-G95-1)

Industrial Chemicals

Industry representation at Federal, and State, regulatory agencies

Risk Assessment ( Nationally recognized)

Food Additives

Product Safety

CTD filing

Opthalmic and Dermatological Products

Carcinogenicity bioasays, assessment, risk (Leading role), CAC Chairman/FDA

Plastics, Safety

Good Laboratory Practice (GLP)

Consultant Training, Anticancer Agents

Litigation and arbitration

Literature search, online and at NIH and NLM

Animal Drugs

Training for Toxicology Consultants