Regulatory Solutions

We provide consultancy in the regulatory affairs in the areas of API’s, Formulations, Medical Devices and In-vitro Diagnostic Kits: Our regulatory skill set comprises of:

1. Site and Product Registration
2. New Product Approval
3. Bio-equivalence/ Bio-Availability Studies
4. GEAC Approval
5. Dossier development & Technical Files
6. Free Sale Certificate
7. NOC’s for Surgical & Cosmetic Products
8. Export Permissions
9. Embassy attestation
10. ISO 13485:2003 & CE Certifications as per EC Directives 93/42/EEC and 98/79/EC
11. ‘European Authorized Representative’ as per European Directives.
12. US FDA approval
13. India Representation Services
14. USA Regulatory Agent
15. Quality management System
16. CMDCAS (Canadian Medical) Approval
17. Risk Management Services according to EN ISO 14971:2000