Submission Management & Publishing
SubmissionExpert™ consolidates submission management and publishing capabilities within one unique solution.
- 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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