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Any sound regulatory strategy stands on effective planning and implementation. Regulatory Operations by way of New Filings, dossier compilations or variations, running procedures on client’s behalf, regulatory due diligence etc form the heart of Regulatory Affairs. We at DDReg have made a name for us, to run regulatory operations effectively and with top class quality for our clients.

  • Services include
  • Dossier Compilation for Emerging Markets/EU/US/Australia
  • Types – eCTD, ACTD. NeeS, National Filing
  • Dossier conversions to CTD/ACTD for Drugs & to CSDT for Medical Devices
  • PIL User Testing
  • Labelling Reviews as per National requirements
  • CPP Reviews
  • API Related

    • DMF Review

    • API filing with EDQM for obtaining CEP

    • Assessment/Review and filing of Amendments/Variations

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