Shailesh Biradar

Background

About Shailesh Biradar

A pharmaceutical professional with Doctor of Philosophy (PhD in Pharmacy) and 21 plus years of exposure to fascinating research world of drug product development (17 years of industrial research experience) Successfully developed and filed, marketing authorization for multiple innovative branded & complex generic oral pharmaceutical drug product with US FDA, EMA and ANVISA Expertise in formulation development, process development, & technology transfer for oral dosage forms (Tablet, capsules, powder for oral suspension, oral liquid & extended-release oral drug products) Bring 17 years of rich industrial research experience and worked as both as individual contributor (Formulation scientist) as leader (Team lead, CoE-Head & CMC-Head) for Research & Development (R&D) center of Indian multinational (Emcure, Torrent, Sun Pharma, Cadila Healthcare & Aurobindo Pharma) and US and Europe based multinational pharmaceutical companies (working with Ferring Pharmaceutical & worked for Nesher Pharmaceutical, USA) Sound knowledge of regulatory/intellectual property sciences and proficiency in “LCM branded” or “generic” drug product development via IP mapping, strategic formulation development, mitigation of bioequivalence challenge, compliance to regulations, leading to successful NDA/ANDA submission Handled regulatory agency’s query in form of response to common deficiencies in IR letter, CR letter and pre-approval inspection (PAI)