eCTD Viewer and Reviewer Software — DnXT Reviewer
eCTD viewer and reviewer, the way the agency sees it
DnXT Reviewer imports any eCTD sequence and shows the current and cumulative view of each application — with FDA forms rendered, large study reports opening fast, and every dossier you can access searchable from one place.
Reviewing a pile of sequences is not reviewing an application
The agency sees a lifecycle: what is current, what was replaced, what was asked and how it was answered. A folder of sequences, a stock PDF viewer that shows FDA forms as a blank page, and a study report that takes a minute to open make that picture hard to see.
DnXT Reviewer rebuilds it from what you filed, so the people who answer for a submission can see exactly what is in it.
Built for the people who own the outcome
Regulatory affairs and reviewers
Walk the current application before and after filing, with lifecycle resolved and every form readable.
Publishing QC
Check the assembled sequence exactly as the agency will receive it, links and bookmarks included.
Partners, due diligence and audit
Navigate a dossier you did not build by structure and search, with access scoped to exactly what you were granted.
From sequence to understanding
Import
Upload sequences, or sync from Veeva-managed content.
Resolve
New, replace, append and delete are resolved into current and cumulative views.
Review
Read, compare versions and follow links and bookmarks as the agency would.
Understand
Search, chronology and history across every application you can access.
What an eCTD viewer should do — and what Reviewer does
Current and cumulative views
Lifecycle resolved across every sequence, with a badge on every document showing whether it is new, replaced, appended or deleted.
FDA forms rendered natively
Dynamic FDA forms — 1571, 356h, 2253 and 3674 — that stock PDF viewers show as a blank page are displayed in full inside the workspace.
Large files streamed
Large study reports open at the first page in seconds instead of downloading in full.
Search across every dossier
Keyword and meaning-based search across every dossier you can access, with results landing in the right module and section.
Clinical development history
Protocol versions, agency letters and clinical holds as a timeline — each agency request in its own words, linked to the response.
Reports from what you filed
Submission chronology, agency correspondence, product specifications and labeling history, built from the filed sequences.
Five tests for any eCTD viewer
A viewer looks simple in a demo. Load one of your own applications and check:
- Does it show the current view? Not just a list of sequences, but what is in force today after every replace and delete.
- Can you open the FDA forms? Try a 356h or 1571 from a real sequence. Many viewers show a blank page.
- How long does a large study report take to open?
- Do links and bookmarks land where the agency’s will?
- Can you give a partner access to one dossier and nothing else?
Frequently asked
What is an eCTD viewer?
Software that opens eCTD sequences the way a health authority reviewer sees them: it reads the backbone, resolves lifecycle operations across sequences, and presents the application by CTD structure rather than as raw folders and files.
What is the difference between an eCTD viewer and an eCTD reviewer?
The terms are often used interchangeably. A viewer displays sequences; a review platform adds what teams need to work with them — search across applications, version comparison, history, reports and controlled access for partners. DnXT Reviewer does both.
Can DnXT Reviewer open FDA forms such as the 356h and 1571?
Yes. Dynamic FDA forms, including 1571, 356h, 2253 and 3674, are rendered in full inside the workspace.
Can we view sequences built in another publishing tool?
Yes. Reviewer imports eCTD sequences regardless of the tool that built them, and can sync from Veeva-managed content.
Can external partners review a dossier?
Yes. Access is granted per dossier, so a partner, auditor or due-diligence team sees exactly what they were given and nothing else.
Bring a dossier you know
We will import it and show you its current view, its forms and its history.
