Regulatory Services

The one stop solution for Regulatory Operations

Our expert Regulatory Operations team are well equipped with exclusive and state-of-the-art technology. We’re capable of tracking, executing and managing the regulatory operations activities of all submission types for our clients.

We help our clients with

  • Document Publishing, including all submission types and formats.
  • Submission Publishing, including NeeS and eCTD publishing.
  • DMF and document management.
  • Drug Establishment Registrations and GDUFA self-identification

Our Regulatory pre-approval services

  • USDMF, CEP, ASMF (EU), TGA, Health Canada, and global registration submissions.
  • CMC activities for customers
  • EDQM Certificate of Suitability applications.

Our Regulatory post-approval services

  • End-to-end life cycle management service supporting licence maintenance (variations, renewals, annual reports)
  • In-country support.
  • Regulatory intelligence.
  • Site rationalisation regulatory support.
  • DMF gap analysis
  • Stability data assessments
  • CTD conversions (content and format)
We can help you
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