DnXT Reviewer: Purpose-Built eCTD Review for Regulatory Teams
Here is a question worth asking at your next team meeting: when your regulatory reviewers open a published eCTD sequence, what are they actually using?
In most organizations, the answer is the viewing component bundled with their publishing software. It loads the sequence. It renders the TOC. It lets you click through documents. And that’s roughly where its usefulness ends. Annotation is limited or nonexistent. Collaboration means emailing marked-up PDFs. And if you need to share access with a CRO partner, you’re looking at VPN credentials, license negotiations, or workaround after workaround.
This is what happens when review is treated as a secondary function — a checkbox tacked onto a publishing platform. DnXT Reviewer takes the opposite approach. Review isn’t the afterthought. It’s the entire point.
Instant Structure from the XML Backbone
When you load an eCTD sequence into DnXT Reviewer, the platform reads the XML backbone and immediately reconstructs the full dossier structure. You’re not browsing a folder of PDFs — you’re navigating a complete regulatory submission with its hierarchy, lifecycle operations, and document relationships intact. Modules, sections, leaf elements, and their associated metadata are presented exactly as the health authority will see them.
This structural awareness is what separates a purpose-built review tool from a document viewer. Every annotation, every comment, every review decision is anchored to the regulatory context it belongs to — not just a page in a PDF.
Annotation That Works the Way Reviewers Think
DnXT Reviewer provides a full annotation toolkit designed for regulatory document review: highlighting, underlining, strikethrough, and text comments. Annotations persist across sessions, are tied to specific users, and are visible to anyone with the appropriate access. There’s no merging of separate markup files, no version confusion, and no need to reconcile who said what in which email thread.
For teams conducting internal quality reviews before submission, this changes the workflow fundamentally. The reviewer marks up the document inside the platform. The publishing specialist sees the annotations in context. The corrections are made, the sequence is republished, and the reviewer can confirm resolution — all within the same system.
Role-Based Access for CRO Collaboration
If you work with contract research organizations — and nearly everyone does — you know the access problem. CRO reviewers need to see specific sections of your dossier without seeing everything else. They need to annotate without altering. And you need to provision and revoke that access cleanly, with an audit trail.
DnXT Reviewer handles this through role-based access controls. You define what each user or user group can see and do. External reviewers get exactly the access they need, scoped to the sections relevant to their work. When the engagement ends, access is removed. Every action is logged. No shared credentials, no VPN headaches, no ambiguity about who reviewed what.
Veeva Vault Bi-Directional Sync
For organizations using Veeva Vault as their document repository, DnXT Reviewer integrates directly. Documents flow from Vault into review workflows, and review status, annotations, and decisions can sync back. This eliminates the manual handoff that typically sits between your document management system and your review process — a handoff that introduces delays, version mismatches, and unnecessary manual effort.
AI Copilot Panel
DnXT Reviewer includes an integrated AI copilot that operates within the review context. It can analyze document content, flag potential inconsistencies, summarize sections, and assist reviewers in identifying issues that might otherwise require line-by-line comparison. The AI works alongside the reviewer — it doesn’t replace judgment, but it augments the reviewer’s ability to cover more ground with greater confidence.
Chronology and Labeling History
For lifecycle products with extensive submission histories, DnXT Reviewer provides chronology views and labeling history reports. You can trace how a section evolved across sequences, understand the progression of lifecycle operations, and generate reports that support regulatory strategy discussions. This is the kind of capability that matters when you’re preparing a variation strategy or responding to a health authority question about prior submissions.
The Core Argument
Your publishing vendor’s viewer exists to confirm that publishing worked. DnXT Reviewer exists to make review a disciplined, collaborative, and efficient process in its own right. For a Senior Director building a regulatory operations capability that scales, that distinction matters. Review quality directly affects submission quality — and submission quality directly affects approval timelines.
If your team is still reviewing eCTD sequences with tools that were designed to do something else, see what a dedicated review platform looks like.
