DRA Officer

Role & responsibilities

1. Follow up from plant R&D Team for AMD, AMV, Tech Transfer, Stability Charging Date, AMV timeline

2. Follow up with Purchase Department for API Documents and review of API Documents of vendor

3. Dossier Compilation & Review of both Finished Product and API

4. Preparation of all technical document of dossier like package insert, rationale, drug-drug interaction.

5. Review of artwork for DCGI

6. Prepare all modules (Module 1,2,3,4 & 5) and submit to CDSCO

7. Prepare Dossier for IPC Submission and reply of Subsequent Queries Independently

8. CT-16 application for import of new API and new RLDs

9. CT-10, 12 & 13 application(Form-29)

10. Reply to Business Development Department on Technical Queries received from Clients "

11. Review of CT & BE Protocol

12. Form 12 & CT-17 application to CDSCO