
Outsourcing of Preclinical Studies - A Trend Reflecting Regulatory & Business Demands
With 20+ years experience in toxicology, Dr Stewart has 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, he has contributed to the production of 200+ regulatory documents and has a working knowledge of program development/management. In the program development/management role, he primarily provides multidisciplinary preclinical advice to small/midsized pharmaceutical companies that lack their own staff toxicologist/pharmacologist in an effort to keep a program moving forward.