Agatha’s immediately available regulatory module enables organizations to manage regulatory documents prior to submission, and to browse the existing submission archives.


In addition to a complete set of document management functions, Agatha provides unique capabilities to greatly improve your organization productivity and compliance including:

  • Collaboration with external partners.
  • Management of expected documents per product (as per the EDM Reference Model).
  • Integration with eCTD submission software.
  • Online review of documents with annotations.
  • eCTD import and viewer with link remap.
  • View applicable documents across several submission sequences.

Contact us for a demo, or start a free trial.


Also, check out how Agatha can help with your SOP, Clinical and Quality documentation.



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