About DnXT Solutions
Regulatory software, built by people who file
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.
Regulatory expertise and software engineering, in one team
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.
One platform for regulatory operations
DnXT Planner
Submission planning and tracking, registrations, correspondence and commitments.
Planner →DnXT eDMS
Controlled documents, review against sources, Part 11 signatures, labeling and quality.
eDMS →DnXT Publisher
eCTD publishing and validation for 16 regions, including Japan eCTD 4.0.
Publisher →DnXT Reviewer
Every application, current and historical, with forms, search and development history.
Reviewer →And the people to run it with you
Submissions, assembled and published
Our team plans, assembles and publishes sequences with you, from a plan you confirm.
Publishing services →Vault RIM, configured well
Labeling, content planning and Quality–Regulatory integration for companies on Veeva Vault.
Veeva advisory →Principles we build to
Correctness before convenience
Regulated work is judged on whether it is right. We would rather refuse an action than let the system quietly do the wrong thing.
Derive, do not retype
A fact that is already in a filed document should not be typed in again. The platform reads it, and a person confirms it.
People decide
Automation and AI propose; a named person accepts. Every decision is on the record.
Say only what we can prove
We describe what the software does, not outcomes we cannot show you on your own data.
Eight offices on three continents
Regulatory, engineering and services teams in the United States, Europe and Asia.
Newtown Square
Pennsylvania
Philadelphia
Pennsylvania
Lake Hopatcong
New Jersey
Boston
Massachusetts
Turku
Finland
Kathmandu
Nepal
Bengaluru
India
Delhi
India
Talk to the people who build it
Bring a submission, a dossier or a question. You will speak with people who do this work every day.
