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  • eCTD Readiness

    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

    © 2007 - 2017 | Exalon GmbH | Fritz-Reichle-Ring 2 | 78315 Radolfzell | Germany | Phone: +49 (0)7732.939.1650 | Fax: -.1655 | e-Mail:info@exalon.com