Good knowledge of US ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. Exposure of the Solid oral dosage form/Liquid Oral/Transdermal dosage form / topical-Inhalation dosage form and brief manufacturing process and key regulatory aspects. Ability to review the change cases with
Be the First to Apply DivisionPiramal Pharma Solutions Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a
Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. API DMF and DMF Change Notification review with respect to USFDA regulatory requirement. Exposure of the Solid oral dosage form / Sterile dosage form / complex dosage form /