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
