01Plan
DnXT Planner
Know what is due, in which market, and who owns it.
- Submission plans from templates, with market variants
- Document-level tracking and timelines
- Registrations, correspondence and commitments in one place
The products
Plan, author, publish and review — on one platform
Four products that share one record of your applications: DnXT Planner for the plan, DnXT eDMS for controlled documents, DnXT Publisher for eCTD sequences in 16 regions, and DnXT Reviewer for every application, current and historical.
4products, one record
16eCTD regions
Part 11audit trail and e-signatures
The products
Four products. One record.
Each one is strong on its own, and better together.
02Author and approve
DnXT eDMS
Controlled documents, ready for review, signature and inspection.
- Review against sources, with Document QC
- Part 11 eSignature and a full audit trail
- Labeling against the CCDS; quality processes in early access
03Publish
DnXT Publisher
eCTD sequences for 16 regions, built from the record.
- 16 regions, including Japan eCTD 4.0
- The envelope from the record, the lifecycle from the current view
- Validation as you build, not after
04Review
DnXT Reviewer
Read every application the way the agency will.
- Cumulative and current views, lifecycle resolved
- FDA forms rendered; large files streamed
- Search across dossiers and clinical development history
How they connect
One record from plan to agency
The joins are where separate tools fail — the plan disagrees with the sequence, or the published file is not the approved one. In DnXT they are the same record.
Plan → documents
The submission plan names the documents each sequence needs, with owners and status.
Documents → sequence
Approved eDMS documents are placed into Publisher sequences with their QC results.
Sequence → review
Published sequences appear in Reviewer’s current and cumulative views.
Agency → plan
Correspondence and commitments are recorded against the application they belong to.
Modules
Add what your team needs
Module
Labeling
Local labels against the CCDS, change classes and a due date for every market.
Labeling →Module
Regulatory Intelligence
Guidance and rule changes assessed against your own products and markets.
Regulatory Intelligence →Early access
Quality Processes
Change control, CAPA and deviations linked to each affected market’s filing.
Quality Processes →Go deeper
Platform, features and comparisons
Platform
Platform & Security
Azure hosting, separate customer databases, access denied by default, Part 11 audit trail and a governed AI gateway.
Platform & Security →Features
All features
Every capability, from Document QC and eSignature to Japan eCTD 4.0, search and integrations.
All features →Compare
Compare DnXT
How DnXT compares with other approaches to regulatory publishing and information management.
Compare DnXT →Integrations
Integrations
How DnXT connects with your document management, clinical and content systems.
Integrations →Validation
eCTD validation
Submissions checked against each region’s validation rules before they go to the agency.
eCTD validation →For leaders
For regulatory leaders
Portfolio visibility, audit readiness and approval workflows for heads of regulatory.
For regulatory leaders →Services
People who run it with you
Questions
Frequently asked
Do we need all four products?
No. Each product works on its own and connects to the others when you add them.
Where is DnXT hosted?
On SOC 2 Type II certified Microsoft Azure infrastructure, with each customer’s data in its own database schema.
Related
See the platform on your own work
Bring a plan, a document, a sequence or a dossier. We will show you the products working on it.
