Karuna Sachdeva, Ph.D., DABT has over 10 years of experience in the areas of regulatory toxicology, impurities assessments and non-clinical toxicology testing and evaluation. She has contributed to the design of several drug product non-clinical development programs to meet regulatory milestones and to facilitate initiation/continuation of human clinical trials and marketing approval. In addition to her experience working for drug innovators and a generic pharma company, Karuna has also served as a toxicology consultant/scientific expert for the Therapeutic Products Directorate (TPD) of Health Canada providing scientific advice and recommendation on submitted non-clinical data (e.g., pharmacology, non-clinical pharmacokinetics, toxicology, genotoxicity) and/or issues related to qualifying impurities in the drug substance or drug product on selected new drug submissions filed by pharmaceutical companies.
Dr. Sachdeva received her Ph.D., in Pharmacology and Toxicology from the University of Rhode Island and is a Diplomate of the American Board of Toxicology (DABT). She has served as a regulatory toxicologist at companies such as ApoPharma (innovative drug division at Apotex Inc.), Abbott Laboratories, and Wyeth Research.