Navigable Files

The data and document files that form part of a submission are mostly provided in a portable document format (PDF) and are embedded into the XML backbone of the eCTD.

One major advantage of an eCTD is its ability to allow navigation through the complete electronic submission - provided that each file is navigable itself and provided referenced files are hyperlinked.

In order to become “navigable,” the portable document files (PDFs) which form part of an eCTD need to fulfill specific formal requirements (e.g., document granularity) and need specific properties which allow navigation, like bookmarks, intra- and inter-text hyperlinks.

PhACT supports its clients with creating navigable, eCTD-compliant submission files.