The generation of eCTD-ready documents often turns out to be more time consuming than the eCTD publishing itself. In order to pass technical validation at regulatory agencies you have to consider a long list of tedious technical and formal requirements.
Exalon supports you by making your documents and your processes truly eCTD-ready by providing the following services:
eCTD Readiness Assessment: - Assessment of your regulatory documents regarding eCTD compliance
- Dossier check
- Review of internal document templates and style guides
- Provision of eCTD templates
- PDF Rendition settings
Document Processing and Formatting - Publishing of complex and composed documents like ICH E3 study reports
- Conversion of paper dossiers to eCTD incl. scanning and text recognition of paper documents (from single volumes to large scale submissions)
- Bookmarking and hyperlinking of PDF documents incl. CRF bookmarking and hyperlinking per domain and visit (as per FDA requirements)
- Formatting of Word documents
- PDF rendition
- Transfer of labeling information into XML based SPL files for U.S. eCTDs
- Management and printing of paper hardcopies
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