Publishing Services — eCTD Submission & Document Publishing
Publishing Services
Document publishing and eCTD submission publishing, run as an outsourced desk for sponsors who would rather not hire a publishing team — delivered by the people who build the publishing platform.
Two service lines, priced and staffed separately.
Publishing gets sold as one thing and it is really two. Getting a Word file to a compliant, submission-ready PDF is document work. Getting forty of those PDFs into a valid sequence that an agency gateway will accept is submission work. They need different skills, they carry different risk, and mixing them into a single blended rate is how sponsors end up paying submission rates for formatting.
Document Publishing
Source documents to submission-ready renditions. PDF settings compliance, bookmarks to the required depth, internal and cross-document hyperlinks, pagination, granularity and file naming — then a document-level QC pass that finds the defects before the sequence is built on top of them.
Submission Publishing
Sequence assembly through to dispatch. Backbone XML, leaf placement and lifecycle operations across sequences, regional forms, validation against the applicable criteria, and the archive copy your records need afterwards.
Most of this work is not the next sequence. It is the last five.
Sponsors rarely call a publishing desk because everything is clean. They call because a legacy dossier has to move systems, or because nobody can prove that what was filed is what is on the shelf. On a typical engagement, routine sequence publishing and remediation of prior sequences run side by side for months.
Reconciling what the backbone references against what is actually on disk, across every sequence of an application — and reconstructing or re-sourcing the gaps.
Repairing malformed or inconsistent XML inherited from a previous vendor or a previous tool, without disturbing the lifecycle chain.
Republishing historical sequences so an application that has changed hands, tools or vendors reads as one coherent dossier again.
Moving an application into a new environment, publishing it in a sandbox first, proving it, and only then repeating it in production.
Working a defect list document by document — the unglamorous pass that decides whether the next validation run is clean.
Scope we publish into.
If your target region is not listed, ask. The publishing platform underneath this service covers 13 eCTD regions; the list below is what our desk publishes into routinely.
Applications
From the first sequence through the life of the application.
- IND, NDA, BLA and lifecycle maintenance
- Sequence 0000 through ongoing lifecycle
- Grouped and multi-application submissions
- Gateway-ready output and archive copies
Formats and lifecycle
Every operation, in both current eCTD versions.
- eCTD 3.2.2 and eCTD 4.0
- New, replace, append and delete operations
- Study tagging files and multi-study modules
Regions
Regional requirements handled as part of the sequence.
- US FDA, EU, Health Canada
- Regional forms and Module 1 content
- Validation against the applicable regional criteria
Engagement model.
Master services agreement with a statement of work per scope. Ongoing desks run monthly; one-off remediation and migration projects are scoped and fixed.
Document publishing and submission publishing are billed at separate hourly rates, tracked and reported separately. You see which hours went to formatting and which went to the sequence.
A monthly activity breakdown by week, by application and by service line — not a single line item.
We publish on the DnXT platform. You are not buying a licence to get the service, and you are not locked in if you later want the software.
Output is a standard eCTD sequence plus its validation report and archive copy. It is yours, in an open format, whatever you do next.
Client-identifying detail is never used in our marketing. Every engagement runs under mutual confidentiality, and we do not name sponsors without written consent.
You confirm the plan. You receive the sequence.
A plan you review, not a spreadsheet
For every sequence you get a secure link to its plan: each document, its section and whether it is new or replaces something already filed. Confirm a row, or flag it with a note. You also check the application details we hold — applicant, products, contacts — and tell us if anything is wrong.
Your notes become the change
“Replace the earlier protocol” is matched against what has actually been filed. Where the history gives one answer it is applied; where several versions are in force, a publisher decides and shows you what was chosen.
Checked against your plan before it ships
Before publishing, the sequence is compared with the plan you confirmed, every document’s approval is checked, and the validation run is compared with the previous one, so you see exactly what changed.
Delivered through the same portal
The published sequence arrives as a download through your secure link, with every download recorded. No file-transfer attachments, no wondering which version you were sent.
We publish on software we wrote.
The tool is not a black box to us
When a validation criterion fires on an edge case, most publishing vendors file a ticket with their software provider and wait. We are the software provider. A defect found on your submission becomes a fix in the platform, usually in the same week.
Remediation is the normal case, not an exception
A desk that only knows how to publish sequence 0000 is of limited use. Ours spends a substantial share of its time on inherited dossiers — missing files, legacy XML, mid-lifecycle applications that changed vendors — because that is what sponsors actually have.
Separate rates keep the incentives honest
Billing document work and submission work at one blended rate rewards the vendor for doing the cheap work slowly. Splitting them means you can see, every month, exactly where the effort went.
A path off the service, if you want one
Some sponsors want a permanent outsourced desk. Others want cover while they build the capability in house. Because the desk runs on our platform, moving from “you publish for us” to “we publish ourselves” is a change of who logs in, not a migration project.
What this is and is not.
Publishing execution — document renditions, sequence assembly, validation, dispatch and archiving — plus remediation of what already exists.
A named team you can reach, working to your timelines, reporting against your applications.
Regulatory strategy, authoring or medical writing. We publish what your regulatory team decides to file; we do not decide what to file.
A software licence. If you want the platform itself, that is a separate conversation — see the platform features.
Start with one application.
The cheapest way to test a publishing desk is to hand it one real application — ideally a messy one — and see what comes back. We will publish or remediate a single sequence, give you the validation report against a control, and tell you plainly what we found in what you already have.
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