Mr. Hitesh Shah has a Masters degree in Pharmacology and Diploma in Pharmacoeconomics with more than 15 years of rich experience in various facets of Pharmaceutical fields including BA/BE studies, Pre-clinical studies, Clinical Trials, Formulation and Regulatory Affairs. He has conducted more than 500 Pharmacokinetics studies with various study designs. He has successfully faced regulatory inspections from DCGI - India, UK MHRA, US FDA, EMA, ANVISA- Brazil, WHO, MCC- South Africa, MoH-Turkey and Israel- MOH. He has worked previously with Wellquest Clinical Research Organization, Macleods BA/BE centre, DIL Group (formerly duphar –Interfran Ltd.) and DMRI. He has international publications to his credit.
BA/BE studies, Pre-clinical studies, Clinical Trials, Formulation and Regulatory Affairs.