This candidate is an accomplished pharmaceutical professional with over 25 years of experience. Holding an M.Pharm degree, they specialize in Generic medicines, with expertise in Bioavailability & Bioequivalence Studies, Formulation & Analytical Development, and Quality Systems. They successfully established a state-of-the-art BA/BE facility within a specified budget. Their extensive background includes involvement in over 1000 bioavailability and bioequivalence studies across major regulatory regions, with a track record of facing audits from various agencies. They excel in developing technical SOPs, eCTD, and regulatory dossiers, and have strong leadership skills. Additionally, they've published research articles and actively participate in training programs. Their academic background includes an M.Pharm and B.Pharm from Jamia Hamdard University.