1 Preparation and submission of registration and re-registration dossiers as per country requirements of ROW Preferable Russia CIS countries and WHO 2 Arrangement for indent of Samples Packing Material specimen Impurities Reference Standards as per submission requirement 3 Query evaluation and submission with respective countries requirement within the required time frame 4 Establish coordination with other departments like QA QC R D Marketing and Purchase for ensuring the filings and query response within time frame 5 Post approval activities Submission of variations to the terms of marketing authorizations for finished products as per respective variation guideline 6 Preparation of COPP s Certificate of Pharmaceutical Product and FSC to be submitted to Local FDA approvals 7 Preparation of Tender documents 8 Support for activities of contract manufacturing product