REGULATORY SERVICES
Our ability to assist sponsors obtaining regulatory approvals is supported by a deep understanding of, and experience in dealing with the Indian drug control regulations. We have the ability to provide services as a complete study management and/or as customized services.
Services
- Regulatory dossier compilation.
- Regulatory approvals for Phases II-IV, device studies and BE studies.
- Approval of Import license of drugs.
- Safety reporting.
- Product registration for marketing approval.