regulatory

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.