Experienced in the field of In Vitro/Vivo Toxicology Testing and Evaluating Chemicals, Agrochemicals, Pharmaceuticals, Food Additives, Cosmetics and Medical Devices. Experienced in development of preclinical program right from study design (protocol), conducting, monitoring and reporting. My area of specialisation is Genetic Toxicology. Training and Managing staff, Knowledge of various regulatory requirements and guidelines OECD, ICH, FDA, EPA-OPPTS, JMHLW, EMEA and ISO. Instrumental in various sponsors and GLP inspections. Reviewed draft ISO guidelines for Biological Evaluation of Medical Devices (10993-3 and 10993-12).
Specialties: In Vitro and In Vivo Toxicity Studies.
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