<ul><li>Follow up from plant R&amp;D Team for AMD, AMV, Tech Transfer, Stability Charging Date, AMV timeline</li><li>Follow up with Purchase Department for API Documents and review of API Documents of vendor</li><li>Dossier Compilation &amp; Review of both Finished Product and API</li><li>Preparation of all technical document of dossier like package insert, rationale, drug-drug interaction.</li><li>Review of artwork for DCGI</li><li>Prepare all modules (Module 1,2,3,4 &amp; 5) and submit to CDSCO</li><li>Prepare Dossier for IPC Submission and reply of Subsequent Queries Independently</li><li>CT-16 application for import of new API and new RLDs</li><li>CT-10, 12 &amp; 12 application(Form-29)</li></ul>

DRA Officer