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Expert consulting + intelligent software for eCTD submissions, document management, and regulatory planning. The only platform where your submission plan, documents, reviews, and publishing live in one connected system.
No imports, no exports, no reconciliation. Everything connected from planning to gateway.
eCTD compilation, validation, and submission publishing for FDA, EMA, Health Canada, and 16 eCTD regions. Supports 3.x and 4.0 (HL7 RPS), grouped submissions, deterministic auto-placement, and each region’s own validation criteria — over 2,500 in all.
Explore Publisher →eCTD review built for how agencies read: cumulative and current lifecycle views, native FDA form (XFA) rendering, large-file streaming, cross-dossier search, and AI-assisted suggestions, version diff, and chronology.
Explore Reviewer →Submission planning and regulatory intelligence in one place: eCTD-aware plans, document-level tracking that replaces spreadsheets, portfolio-aware agency monitoring, predictive health-authority question readiness, and correspondence tracking.
Explore Planner →Compliant document management beyond regulatory: Part 11 e-signatures with cryptographic verification, compliance domains across quality and clinical, training management, and inspection readiness with one-click audit packs.
Explore EDMS →CCDS compliance built into the document system: structural comparison of local labels against the Company Core Data Sheet, forced adjudication of every difference, per-market submission due dates driven by configurable change classes, and an artwork gate that will not open without an approved change control.
Explore Labeling →Veeva Vault advisory across RIM and Quality — enablement and configuration, process consulting, training, and ongoing support — delivered by people who have repaired these systems, not just implemented them. Every engagement includes our Vault Knowledge System, and the Vault Health Check is a read-only assessment that surfaces the backlogs nobody is watching.
Whether you lead the team or manage the documents, DnXT solves your specific challenges.
Start with a consultation. Our regulatory experts will map your current workflow and show you exactly where DnXT fits.
What IT, security and quality teams want to know: where DnXT runs, how customer data is kept apart, how access is decided, what is recorded, and how regional rules and AI are governed.
Hosted on SOC 2 Type II certified Microsoft Azure infrastructure. Traffic encrypted; sessions time out.
Security →Each customer’s data is held in its own database — separation is structural, not a filter.
Data separation →Microsoft Entra ID or Okta sign-in; access denied by default and granted per role and per dossier.
Security and SSO →Who did what and when, recorded across the products and available for inspection.
Audit trail →Signer, time and meaning recorded, for internal and external signers.
eSignature →Requirements, risk and test evidence to support your computer system validation.
Validation guide →Module 1, vocabularies and validation criteria for 16 eCTD regions — more than 2,500 criteria.
Regions →Keyword and meaning-based search, filtered by each user’s access on every query.
Search →Every AI feature through one gateway: provider per customer, features enabled individually, usage limits.
AI gateway →Configurable review and approval routes with signatures at each step.
Workflow →Veeva Vault, SharePoint, Box and Egnyte as document sources.
Integrations →PDF properties, fonts, bookmarks and links checked where documents are created and approved.
Document QC →DnXT is hosted on SOC 2 Type II certified Microsoft Azure infrastructure.
Each customer’s data is held in its own database.
We will walk your teams through the foundations, in the product.
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.
Submission plans from templates with market variants, document-level tracking, timelines, registrations, correspondence and commitments.
Planner →Controlled documents, review against sources, Part 11 eSignature, Document QC, labeling against the CCDS, and quality processes in early access.
eDMS →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 →Cumulative and current views, FDA forms rendered, large files streamed, search across dossiers, and clinical development history.
Reviewer →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.
No. Each product works on its own and connects to the others when you add them.
On SOC 2 Type II certified Microsoft Azure infrastructure, with each customer’s data in its own database.
Bring a plan, a document, a sequence or a dossier. We will show you the products working on it.
DnXT Solutions was founded on a simple conviction: regulatory operations should accelerate approvals, not slow them down. We build the software regulatory teams use to plan, author, publish and review submissions — and we use it ourselves.
Our team combines regulatory operations experience with modern software engineering. The people who design DnXT have assembled, published and reviewed submissions themselves, and the platform is shaped by that work: by what goes wrong the night before a filing, by what an inspector asks for, and by what a regulatory team actually needs to see.
We publish and review submissions on the software we build, for biotechs, CROs and pharmaceutical companies — so every rule we encode has been tested against real filings, not only against a specification.
Submission planning and tracking, registrations, correspondence and commitments.
Planner →Controlled documents, review against sources, Part 11 signatures, labeling and quality.
eDMS →eCTD publishing and validation for 16 regions, including Japan eCTD 4.0.
Publisher →Every application, current and historical, with forms, search and development history.
Reviewer →Our team plans, assembles and publishes sequences with you, from a plan you confirm.
Publishing services →Labeling, content planning and Quality–Regulatory integration for companies on Veeva Vault.
Veeva advisory →Regulated work is judged on whether it is right. We would rather refuse an action than let the system quietly do the wrong thing.
A fact that is already in a filed document should not be typed in again. The platform reads it, and a person confirms it.
Automation and AI propose; a named person accepts. Every decision is on the record.
We describe what the software does, not outcomes we cannot show you on your own data.
Regulatory, engineering and services teams in the United States, Europe and Asia.
Pennsylvania
Pennsylvania
New Jersey
Massachusetts
Finland
Nepal
India
India
Bring a submission, a dossier or a question. You will speak with people who do this work every day.
We would be delighted to assist you! Whether you are seeking a demo, an evaluation, or simply want to learn more about how our regulatory publishing and strategy services can benefit your organization, please contact us for a complimentary consultation. We are committed to helping you navigate the regulatory landscape with confidence and efficiency.