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.
Each one strong on its own; better together
DnXT Planner
Submission plans from templates with market variants, document-level tracking, timelines, registrations, correspondence and commitments.
Planner →DnXT eDMS
Controlled documents, review against sources, Part 11 eSignature, Document QC, labeling against the CCDS, and quality processes in early access.
eDMS →DnXT Publisher
eCTD sequences for 16 regions including Japan eCTD 4.0, with the envelope from the record, lifecycle from the current view and validation as you build.
Publisher →DnXT Reviewer
Cumulative and current views, FDA forms rendered, large files streamed, search across dossiers, and clinical development history.
Reviewer →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.
The submission plan names the documents each sequence needs, with owners and status.
Approved eDMS documents are placed into Publisher sequences with their QC results.
Published sequences appear in Reviewer’s current and cumulative views.
Correspondence and commitments are recorded against the application they belong to.
Add what your team needs
Labeling
Local labels against the CCDS, change classes and a due date for every market.
Labeling →Regulatory Intelligence
Guidance and rule changes assessed against your own products and markets.
Regulatory Intelligence →Quality Processes
Change control, CAPA and deviations linked to each affected market’s filing.
Quality Processes →Platform, features and comparisons
Platform & Security
Azure hosting, separate customer databases, access denied by default, Part 11 audit trail and a governed AI gateway.
Platform & Security →All features
Every capability, from Document QC and eSignature to Japan eCTD 4.0, search and integrations.
All features →Compare DnXT
How DnXT compares with other approaches to regulatory publishing and information management.
Compare DnXT →Integrations
How DnXT connects with your document management, clinical and content systems.
Integrations →eCTD validation
Submissions checked against each region’s validation rules before they go to the agency.
eCTD validation →For regulatory leaders
Portfolio visibility, audit readiness and approval workflows for heads of regulatory.
For regulatory leaders →People who run it with you
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.
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.
