CMC review/authoring of Drug/Active Substance Master FilesSuccessfully filed/registered DMFs/ASMFs/COS/MFs across the globeHave got sooner approvals for CEPs/ASMFs and got adequacy & completeness letter from Established Regulatory Authorities Drafting of CMC response to the deficiencies of regional national & international Regulatory Agencies Response to customer queries Liaison with internal & external stakeholders for effective change control management Selection of Regulatory starting materials / Synthetic route for active pharmaceutical ingredients Contribute to the designing of specifications & test methods for API, starting materials. In-process & intermediate etc., for successful & faster approvals Review & approve of change controls Handle trouble shooting, rectify errors and submit error free electronic submissions (eCTD)Corresponding with Regulatory Authorities like USFDA, EDQM, MEDSAFE, TGA, SAHPRA, ANVISA, EMA, Health Canada, Swissmedic, Saudi FDA, Taiwan FDA, NPRA- Malaysia etc., for effective life cycle management of Drug Master Files