Job Profile :
Dossier preparation as per the ACTD & CTD (Module I, II, III, IV and V) guideline.
Technical documents like Raw Material and finished products specification, manufacturing process, Product development report, stability reports, process validations preparation & review.
Analytical method validation review as per the ICH guideline.
Drug Master File review
Technical query response to the various regulatory authorities.
Dosage All Dosages Forms i.e., Tablet, Capsule, Liquid Injection, Dry Powder Injection, Lyophilized Injection, Power Sachet, Syrup, Suspension, Cream, Gel & Ointment etc.