Our regulatory affairs and technical writing services includes but not limited to:
- Providing support and documentation for Establishment/ Site Licenses for pharmaceutical/nutraceutical as needed in USA/Canada
- Project Management
- Preparing application and Submission of Medicinal Product Applications( such as ANDA/ANDS,NDA/NDS) preperation and submission in USA,CANADA, Australia and in emerging market
- Test Specification
- Preparing of Analysis Certifications
- SOP’s writing
- Preparing Summary Reports and trending of EM for Manufacturing Premises
- Protocol and report Writing of Analytical Methods