Qingdong "Karin" Ke, Ph.D., is a board-certified toxicologist (D.A.B.T.) specializing in toxicology, risk assessment, product safety, and regulatory affairs. She is also a European Registered Toxicologist (ERT) and has extensive experience advising clients in conducting safety evaluations and performing risk assessments. She also provides clients with regulatory and litigation support involving a broad range of products, including drugs, dietary supplements, human and animal food/feed, medical devices, cosmetics, household products, pesticides, and industrial chemicals, as well as impurities and other constituents in these products.
Karin provides support to clients to assure that products comply with the regulatory requirements of the U.S. Food and Drug Administration (FDA), Environmental Protection Agency (EPA), California Proposition 65, the European Union (EU) Cosmetics Directive and Regulation, REACH, EU Classification Labeling and Packaging (CLP) regulations, the ASEAN Cosmetic Directives, and other global regulations. She has performed Generally Recognized as Safe (GRAS) determinations for food ingredients, prepared GRAS Notifications for submission to FDA, and Pesticide Inert Petitions to EPA. Her expertise includes developing and improving strategic models for risk assessment and product review.
Prior to joining Keller and Heckman, Karin was a toxicologist and product safety specialist in the consumer products industry, where she performed hazard and risk assessments for human health, reviewed safety of raw materials and formulations, developed and managed models for risk assessment, and ensured product safety and regulatory compliance.
Karin has authored and co-authored numerous scientific articles for peer-reviewed journals and book chapters, some of which were selected as the journal cover story. She is a frequently invited manuscript reviewer for scientific journals, such as Food and Chemical Toxicology, Toxicology and Applied Pharmacology, and Carcinogenesis. She has also served as an adjunct professor at New York University (NYU).
- Past President, Food Safety Specialty Section (FSSS), Society of Toxicology (SOT)