eCTD ReadinessThe 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 requirements such as full electronic navigation functionality via bookmarks, hyperlinks and cross-references, specific PDF settings for the PDF version, the document security, opening options and many more are expected by regulatory agencies to name just a few.
Exalon supports you by making your documents and your processes truly eCTD ready in providing the following services:
eCTD Readiness Assessment:
After significant eCTD experience has now been gained by many agencies, the current trend clearly shows that technical validation criteria are handled stricter than in the past.
- Assessment of your regulatory documents regarding eCTD compliance
- Review of internal document templates and style guides
- Provising of CTD templates
- Consulting on document management and publishing processes
Document Processing and Formatting
- Publishing of complex and composed documents like ICH E3 study reports
- Bookmarking and hyperlinking of PDF documents
- CRF bookmarking and hyperlinking per domain and visit (as per FDA requirements)
- Scanning and text recognition of paper documents (from single volumes to large scale submissions)
- Formatting of Word documents
- PDF generation based on electronic documents
- Transfer of labeling information into XML based PIM (EU) or SPL (US) files
- Management of paper versions (paper copies are still required in many countries)
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