eCTD Publishing — Build, Validate and Publish for 16 Regions
eCTD publishing, checked while you build
Build sequences for 16 regions from your documents and your plan. The envelope comes from the application record, lifecycle is chosen against the current view, and each region’s own validation criteria run before anything is sent.
Most technical rejections are mechanical — and found too late
An envelope typed by hand, a replace that points at the wrong document, a PDF with an unembedded font, a link that opens the right file on the wrong page. None is hard to fix; all are expensive when they surface the night before a deadline.
DnXT Publisher moves those checks to the moment the sequence is built, so the last day is for review, not repair.
Built for the people who own the outcome
Regulatory operations and publishers
Build sequences for every region you file in, with lifecycle and validation handled as you go.
Regulatory affairs leads
See what a sequence contains and what it replaces, in the same current view the agency will see.
Publishing service providers
Run many clients’ applications with each client’s data held separately, and have clients confirm the plan for their sequence.
From documents to a validated package
Create or open the dossier
One dossier per product and authority. Clone an existing dossier to a new region to carry products, substances and applicant across.
Fill in the envelope
Application and submission metadata come from the record and the region’s vocabulary, not free text.
Place documents
Pull from DnXT eDMS, SharePoint, Box or Egnyte through the Content Manager, or upload. Auto-Assign makes a first pass at placement for a person to confirm.
Validate and publish
Run the region’s criteria, fix by severity, compare with earlier runs, then publish the package and its validation report.
What Publisher does
Regional Module 1 and envelope
Each region’s Module 1, backbone and envelope built from its own specification and controlled vocabularies — 16 regions including the US, EU, Japan, Canada, Australia, Switzerland, GCC and China.
Lifecycle from the current view
New, replace, append and delete chosen against the application’s current state; cumulative and current views side by side; US grouped submissions and cross-references.
Validation as you build
More than 2,500 region-specific criteria, graded at the region’s own severity, with a validation history you can compare run against run.
Document QC and Auto Link Verification
PDF properties, fonts, bookmarks and Fast Web View checked as documents arrive; every hyperlink checked against where it actually lands.
Japan eCTD 4.0
Japan 4.0 sequences validated against PMDA’s published rules, including the conditional and retired ones.
Readiness Check and evidence
See what a submission type is expected to contain before you start; afterwards, show what was in force at any point, with status and validation history.
Design decisions
Envelopes are data, not typing
Most high-severity errors are envelope errors. Building the envelope from the record removes the most common cause.
A clone is a start, not a submission
Cloning to a region carries structure and metadata. Module 1 is region-specific and is reviewed before anything is published.
Validate at the agency’s severity
A finding is graded the way the receiving authority grades it, so a clean report means something.
Suggestions are confirmed by people
Auto-Assign and AI-assisted linking propose; a publisher accepts or rejects.
Frequently asked
Which regions does DnXT Publisher support?
Sixteen eCTD regions: the United States, European Union, Japan (eCTD 4.0), Canada, Australia, Switzerland, South Africa, the GCC, Singapore, Thailand, Taiwan, Ukraine, Tunisia, China, Bosnia and Herzegovina, and WHO Prequalification.
Does it support eCTD 4.0?
Yes for Japan, validated against PMDA’s published rules. Other regions are published in eCTD 3.2.2 with their regional Module 1.
Where do documents come from?
DnXT eDMS, SharePoint, Box or Egnyte through the Content Manager, or direct upload.
See it on a sequence of your own
Bring an application you know well. We will build its next sequence with you.
