Mr. Venu Madhav is post graduate in pharmacy and having 19 years of experience in CROs and Pharma companies like Ranbaxy, Sun Pharma. He has expertise in executing biostudies 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 holds expertise in pharmacokinetic and statistical evaluation of data and providing technical write ups to regulatory agencies. During his tenure he could handle regulatory queries of US, Europe, Australia, Canada, Brazil, Japan and other regulatory agencies on study designs, GLP/GCP compliance and regulatory compliance. He has handled successfully more than 20 regulatory inspections from different continents. He has thorough knowledge in biostudies project management.