Submission Management & Publishing

SubmissionExpert™ consolidates submission management and publishing capabilities within one unique solution.


SubmissionExpert™ Features

  • Document linking from a document management repository into predefined submission structures
  • Creating or importing documents directly within a submission structure
  • Management of registered dossier position (agency approved dossier) and version history
  • Submission history tracking for any application through different views; navigation is enabled on sequence, activity or application dossier level 
  • Submission structure export into a file /storage system or published outputs such as PDF, NeeS, eCTD or other XML format  (e.g. EAEU)
  • Publishing of any submission structure for the transfer of a submission
  • Support for regional electronic submission standards (eCTD, NeeS, eDok, EAEU)
  • Global submission planning as a basis for local submissions
  • Documents reuse from global to local submission structures
  • Incremental publishing to allow just-in-time submission compilation
  • Interactive dashboards for actionable submission information overview

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