Bandi Sravan

Hyderabad Area, India India

Regulatory affairs specialist at Graviti Pharma

Medical / Health Care / Pharmaceuticals

Regulatory affairs manager in Graviti Pharma from Oct 2016 to till date. Highly motivated, results-driven Regulatory affairs (Formulation) professional with extensive experience in US-FDA submissions (ANDA, Amendments, labeling, post approval Supplements) and Brazil Anvisa submissions, I have gained knowledge upon regulatory requirements in US, Brazil and China countries. Well versed with complete product lifecycle management (right from inception-review-approval-post approval changes). Specialties: Regulatory Document (ANDA, Controlled correspondence, Petitions) compilation, reviewing and submissions [Electronic Submissions (eCTD) using eCTD software (eDUCE)] Hands-on exposure to •...