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.


  • 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.
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