Master in Pharmacy with over 22 years of very rich professional experience in the field of Business development, Quality Assurance, Regulatory affairs and project management of, Manufacturing, Production, Clinical and Bio-analytical areas of CRO and Pharmaceutical IndustriesWell versed with thorough knowledge in GMP, GCP, GLP and Regulatory requirementsExpertise in handling various regulatory inspections like USFDA, MHRA, ANVISA, EMA, BfarM etc.Excellent analytical, troubleshooting and inter-personal skills with proven ability in driving numerous Quality enhancement, process improvement and effective utilization of resources.Instrumental in developing and reviewing Quality documents, Manuals, policies, SOPs and auditing Bioavailability & Bioequivalence studies and Phase I to IV clinical trials