Nilesh Gandhi is a founder proprietor of the firm Pharma Astute engaged in offering Legal and technical services to Pharmaceutical Industry and supply chain. Nilesh Gandhi is a former Assistant Commissioner (Drugs) in Food and Drug Administration, Maharashtra State. He has fairly good experience in manufacturing, regulatory enforcement and legal services. He has authored along with SW Deshpande a comprehensive publication on commentary on Drugs and Cosmetics Act, 1940 and Rules, 1945, Medical Devices Rules, 2017, New Drugs and Clinical Trials Rules, 2019, Cosmetics Rules, 2020, Drugs Prices Control Order, 2013, Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules, 1955. He is legal and technical services such as drafting regulatory responses, appeals, designing layout plan, conducting gap audits on regulatory compliances in manufacturing and supply chain.