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