Well experienced team works for us for the filing for regulatory submission. Our team keeps upgrading itself by regular training session on new landscape in regulatory environment in India tandem with international regulatory bodies as well. There are very regular follow ups and supplementation with required justification to regulatory requirements. Timely in person meetings & necessary presentation are key factors for us for moving the project in speedy manner. Support to the clients is rendered on:
- New Drugs Approvals
- BA/BE Study protocol Approval
- Import Licenses/Test Licenses
- Export BE NOC’s
- Biowaiver Registration
- Global Clinical Trials NOC’s
- Regulatory Dossier
- Medical Devices registrations
Vaccines & Biologicals registration