eCTD Management Solutions for Life Sciences

The QUMAS eCTD Management Solution is an off-the-shelf electronic management solution that delivers full eCTD and non-eCTD submission capabilities, whether paper or electronic. This solution from QUMAS allows you to build, view, validate and publish compliant submissions based on the following submission structures:

  • CTD
  • eCTD
  • NeeS
  • IMPD
  • CTA
  • eNTA
  • VNeeS

Through a hyperlinking and bookmarking engine, detecting, notifying and correcting broken hyperlinks, the solution ensures high-quality submissions are consistently achieved. An integrated validation function allows compliance of the submissions to ICH and regional specifications.

Alternatively, check out this QUMAS R&D Submission Documents Package from the QUMAS Packaged Solutions, which offers an off-the-shelf approach to R&D Submission Document Management.