M.Pharm with 25+ years of experience in the pharmaceutical industry specializing in bioequivalence studies, formulation and analytical development, stability studies, documentation procedures, and quality systems. Part of more than 1000 bioavailability and bioequivalence studies for all major regulatory regions. Successfully faced audits & inspections from USFDA, ANVISA, DCGI, AFSSAPS, and AGES-Austria. Developed technical (Clinical, Analytical, Statistical)- Standard Operating Procedures (SOPs);eCTD and regulatory dossier preparation. Led a group of scientists in developing robust analytical methods. Comprehensive exposure of Indian and International regulations for Generic drugs. Possesses excellent project management, interpersonal, and leadership abilities.