Maipoojavi GP

US Market

• Responsible in collection, review and compilation of ANDA for USFDA in stipulated time frame
• Accentuate on various aspects of ANDA requirements as per ANDA checklist to streamline the dossier submission by thorough review of CMC documents like manufacturing and packing records (BMRs and BPRs), API, excipient, drug product and packing material specifications etc., considering applicable ICH and cGMP guidelines
• Communicating the loopholes in the reviewed documents with concern cross functional teams and eventually getting the responses or correct documents for final submission
• Application of the strategic regulatory planning to monitor emerging issues and working to identify the solutions and provide the regulatory input to product Life-Cycle management
• Monitoring and updating the Annual reports
• Responsible for preparing prototype assessment for US market
• Preparation and compilation of dossiers in CTD and ACTD format for ROW market

• Preparation of dossiers like Common Technical Document (CTD) format for Nigeria, Niger & Sierra Leone and as per country specific dossiers for Dominican Republic and Guinea.
• Preparation of documents such as Master Formula Record (MFR), Process Validation (PV) and Annual Product Review (APR).
• Preparation of documents for applying drug license, COPP, FSC, GMP certificate.