eCTD Pre-Submission Checklist: 35 Checks Before You Send
eCTD pre-submission checklist
Thirty-five checks experienced publishers run before every sequence — ordered the way a sequence is built.
Ten of the thirty-five
The full checklist covers planning, documents, lifecycle, Module 1, study data, validation and transmission.
- The sequence number is the next unused number for this application and matches its folder.
- Submission type and sub-type are taken from the region’s current vocabulary and are valid together.
- PDFs are text-searchable, unsecured, with all fonts embedded and no embedded scripts or attachments.
- Hyperlinks are relative, point inside the submission, and every target exists.
- Links from Module 2 into the study reports land on the cited page or table.
- Each replace points at the document it supersedes, in the same section, as shown in the current cumulative view.
- Region-specific items are present — for example the US promotional material form, the EU tracking table for variations, or country-specific documents in a segmented Module 1.
- The sequence validates against the target region’s own criteria, graded at the region’s severity.
- Checksums were generated after the last change to any file.
- The package transmitted is byte-for-byte the package validated.
Where things go wrong
Most high-severity errors are envelope errors, and most envelope errors are typing errors.
Security settings, unembedded fonts and broken links are found at validation but caused at authoring.
Lifecycle mistakes often pass validation and surface as a reviewer seeing two “current” versions.
A report only means something if it uses the target region’s criteria at that region’s severity.
The package sent must be byte-for-byte the package validated — late edits break checksums.
The full checklist
Print it, or copy it into your own procedure.
- Plan and envelope — 6 checks
- Documents, PDF and navigation — 9 checks
- Lifecycle — 5 checks
- Module 1, regional — 4 checks
- Study data — 2 checks
- Validation — 5 checks
- Transmission and after — 4 checks
Frequently asked
Which regions does the checklist apply to?
All of them. The checks are written for eCTD 3.2.2 generally, with regional examples. For region-specific Module 1 rules, see the eCTD Regional Reference.
Is this a replacement for validation software?
No. Validation software applies the agency’s criteria precisely; the checklist covers the decisions and checks no validator can make for you, such as whether the right version was approved or a replace targets the right document.
Let the system run the checklist
DnXT Publisher builds the envelope from the application record, checks documents and links as they are added, and validates every sequence against the target region’s criteria as it is assembled.
