Overview #
The DnXT Suite is an integrated regulatory information management (RIM) platform built for pharmaceutical and life sciences organizations. It streamlines the entire electronic Common Technical Document (eCTD) lifecycle — from submission planning and document authoring to regulatory review and compliance tracking.
Whether you’re a regulatory affairs specialist assembling submissions, a reviewer analyzing dossier content, or an administrator managing users and workflows, DnXT Suite provides the tools you need in a unified, web-based environment.
Three specialized applications — Publisher, Reviewer, and Administrator — working together on a single platform with shared data, users, and workflows.
The Three Applications #
DnXT Publisher #
DnXT Publisher is where regulatory teams build and manage eCTD submissions. Key capabilities include:
- Dossier Library — Organize dossiers by product, region, and application type with folder-based grouping and favorites
- TOC Editor — Author submissions using an interactive table of contents tree with drag-and-drop document placement
- Document Management — Upload, version, replace, and track documents throughout the submission lifecycle
- Hyperlink Management — Create and validate cross-references between documents within and across submissions
- Validation & Publishing — Run eCTD validation checks and publish completed submissions
- Global Search — Search across all dossiers and documents from a single interface
- Template Library — Manage reusable submission templates for consistent document structure
- Sync Dossier — Synchronize dossiers between Publisher and Reviewer environments
DnXT Reviewer #
DnXT Reviewer provides a comprehensive environment for reviewing, analyzing, and tracking regulatory submissions. Key capabilities include:
- Import Dossier — Import eCTD submissions from ZIP files, folders, or shared repositories
- Submission Review — Navigate the eCTD table of contents tree with built-in document viewing for PDF, Word, Excel, XML, and image formats
- Annotations & Comments — Add review notes and track document properties
- Chronology Report — View a timeline of all submission sequences and lifecycle events
- Labeling History — Track changes across labeling documents over time
- Specification Dashboard — Monitor specification documents and their status
- Correspondence Tracking — Log and manage regulatory authority correspondence
- Repository Management — Organize the underlying file storage and folder structure
DnXT Administrator #
DnXT Administrator is the central control panel for system-wide settings, users, and security. Key capabilities include:
- User Management — Create, edit, and manage user accounts with role assignments
- Permission Management — Define granular permissions by role for each application feature
- Audit Trail — View a complete log of all user actions across the platform
- System Configuration — Configure SSO/authentication, AI features, repositories, and application settings
- Workflow Manager — Design and manage multi-step approval workflows
- Metadata Manager — Define custom metadata fields and vocabularies
- PDF Rendering — Configure PDF generation and rendering settings
How the Applications Work Together #
The three DnXT applications share a common platform infrastructure:
- Single Sign-On — Log in once and switch between Publisher, Reviewer, and Admin from the user menu
- Shared User Accounts — User accounts and roles are managed centrally in Administrator and apply across all apps
- Dossier Synchronization — Submissions created in Publisher can be synced to Reviewer for analysis, and vice versa
- Unified Repository — All documents are stored in a shared, configurable repository backend
- Consistent Interface — All three apps share the same navigation patterns, toolbar conventions, and visual design
Key Concepts #
| Term | Definition |
|---|---|
| Dossier | A collection of regulatory submissions for a single product/application. A dossier contains one or more submissions. |
| Submission | A single eCTD submission sequence (e.g., Initial Application, Amendment, Supplement) within a dossier. |
| TOC (Table of Contents) | The hierarchical eCTD structure tree that organizes documents into modules and sections. |
| Leaf / Document | An individual document file placed at a specific node in the eCTD TOC tree. |
| Lifecycle Operation | An eCTD action applied to a document: New, Append, Replace, or Delete. |
Getting Started #
Ready to begin? Here’s the recommended path:
- Logging In and Managing Your Account — Sign in and set up your profile
- Navigating the DnXT Interface — Learn the common navigation patterns
- Understanding Roles and Permissions — See what you can do based on your role
FAQ #
What browsers does DnXT Suite support? #
DnXT Suite works best in Google Chrome (recommended). It also supports Firefox, Microsoft Edge, and Safari. Internet Explorer is not supported.
Is DnXT Suite a cloud application? #
Yes. DnXT Suite runs on Microsoft Azure and is accessed entirely through your web browser — no desktop installation required.
Can I use DnXT Suite on mobile devices? #
DnXT Suite is optimized for desktop browsers. While it will load on tablets, the full feature set is best experienced on screens 1024px or wider.
