With 30+ years of experience in toxicology, I have acquired an extensive knowledge of Good Laboratory Practice (GLP) Regulations (including requirements by the FDA, EPA, OECD, and JMHLW) and recommendations by the International Conference for Harmonization (ICH). In addition, I have contributed to the production of 300+ regulatory documents and have a working knowledge of program development/management. In the program development/management role, I primarily provide multidisciplinary advice to small pharmaceutical companies that lack their own staff toxicologist/pharmacologist. In many instances, the advice is associated with troubleshooting issues (from API production/formulation to project scheduling to addressing regulatory agency concerns to estimating a clinical safe starting dose) in an effort to keep a program moving forward.

National Center for Toxicological Research