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Dr. E. Venu Madhav has a Ph.D. in Pharmacy with an MBA in Finance and has 25+ years of rich experience in CROs and Pharmaceutical companies like Ranbaxy & Sun Pharma. He has demonstrated expertise in executing Bio studies from Pilot to Pivotal stage for different formulations like Injectables, Nasal sprays, and Topical preparations besides Conventional dosage forms. He has handled special population studies including patient population studies for oncology products. He has hands-on experience in designing Protocols for IND/NDA/ANDA projects. He has been responsible for developing Complex Bioanalytical methods for Hormonal, Steroidal, and Peptide products. He also has expertise in Pharmacokinetics, Statistical evaluation of data, and providing technical write-ups to Regulatory Authorities. During his tenure, he used to handle Regulatory queries of the US, Europe, Australia, Canada, Brazil, Japan, and other Regulatory Authorities on study designs, GLP/GCP Compliance, and Regulatory compliance. He has so far handled 50+ Regulatory Inspections from across the Globe successfully. He also has thorough knowledge in Bio studies Project Management.