Review of analytical methods validation protocols and reports of Drug substance and Drug product meeting ICH requirements Review of documents Stability guidance documents for Regulatory Dossier submissions Review of Comparative dissolution profiles Assessment IIG elemental Iron content elemental Impurity assessment reports residual solvents assessment reports etc confirming the regulatory requirements for approval of new formulations strategies Specifications review and approvals API Excipients Inprocess Finished Product Stability etc Review and approval of Change control forms Review and comments of API vendor documents e g Techpack DMF COA s and specifcations to make sure they are as per Regulatory requirement for our ANDA submission Review of various study protocols and reports like photostability split study inuse stability multimedia dissolution and alcohol dose dumping as per product requirement To maintain and update regulatory database for the documents from site Vendors etc required for Regulatory submission
