Address Person will responsible for Compilation/ review of supplements ( including Injectable and OSD dosage form) ,Global Annula reports, preparation of summary documents for regulatory submission
- Preparation, Review and Submission of Amendments and supplements for the assigned products
- Prepation of Summary documents for Regulatory submisison
- Preparation, Review and Submission of response to the Agency’s queries for the assigned products
- Compilation and submission of Global Annual Report.
- Review of stability protocols and reports, analytical method validation protocols and reports.
- Review of raw material, packaging material, finished product specifications, finished product stability specification and testing procedure.
- Review of batch records.
- Review of Process Validation Protocol, hold time study protocols and Repots
- Review of Product Development Report
- Review of executed documents including executed BMR, Certificate of Analysis to ensure the compliance with regulatory requirement
