The generation of eCTD-ready documents often turns out to be more time consuming than the eCTD publishing itself. In order to provide reviewer friendly documents that pass technical validation at regulatory agencies a comprehensive list of formal requirements has to be considered.

Exalon supports you by making documents and processes truly eCTD-ready by providing the following services:

eCTD Readiness Assessment:

  • Assessment of your regulatory documents regarding eCTD compliance
    (e.g. document granularity, navigation via bookmarks/hyperlinks, Word styles, PDF settings)
  • Review of internal document templates and style guides
  • Provision of eCTD templates

Document Processing and Formatting

  • Formatting of Word documents
  • Rendition from MS Word to PDF
  • Processing of  PDF documents (e.g. bookmarking and hyperlinks) incl. CRF bookmarking and hyperlinking per domain and visit (as per FDA requirements)
  • PDF rendition
  • Publishing of complex and composed documents such as ICH E3 study reports