We can offer Third Party audit service and consultancy.Our Regulatory Affair and Technical Writing consultancy services are as follows-
- Establishment licence and Site License in Canada/USA
- Project management of Regulatory Affairs activities
- Prepare and submit medicinal product application for marketing authorization in Canada, USA, Europe and emerging market
- Test specification preparation, Certificate of Analysis preparation
- SOPs, Protocols, summary report preparation, Trending of EM for manufacturing premises
- Analytical method development protocol writing, analytical method validation protocol writing
