Submission Management & Publishing
SubmissionExpert™ consolidates submission management and publishing capabilities within one unique solution.
Benefits
User friendly
Create compliant electronic submission outputs without the need of technical knowledge
Consolidation
Consolidate into one common process and approach to submission management independent of the output format (eCTD, NeeS, XML, PDF)
Collaboration
Establish one common place for headquarter(s) and affiliates to collaborate on compilation and publishing activities
Global Submissions
Provide a global submission concept for efficient reuse on local level
Current Registered Position
Provide a current registered position (agency approved dossier) readily available
Automation
Automated compilation and publishing of submissions based on product and application data combined with built-in regulatory inputs
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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