Dr. Vijay Waingankar

Regulatory Affairs

Dr.Vijay has over 34 years of experience in Regulatory Affairs, cGMP, and Quality Assurance across APIs and Formulations for both regulated and emerging markets. His expertise covers global audits and compliances (USFDA, EDQM, TGA, ANVISA, MHRA, NDA, etc.), eCTD submissions and publishing (US, EU, Canada, CIS, ROW), CMC dossier preparation and lifecycle management, DMF and ANDA filings, product labeling in line with FDA and international guidelines, and successful handling of regulatory, customer, and third-party audits. Prior to Harmony Remedies, I held senior regulatory roles in leading pharmaceutical companies, driving compliance, product registrations, and market expansions worldwide.