Resources
Regulatory Operations Resources
A learning path from the fundamentals of eCTD to running a regulatory operations function — written by the people who build and run regulatory software. Read online or download the PDFs.
New to eCTD? Start with the fundamentals.
What Is eCTD?
What a submission is made of, how sequences and lifecycle work, who requires which version, and what gets a submission rejected.
Read →eCTD Module 1 Explained
The regional module: the US twenty-section map and the EU structure side by side, the envelope, and where Module 1 causes rework.
Read →What Is RIM?
Regulatory information management: what it records, why the data drifts from the dossier, and how to keep it true.
Read →Get a sequence right the first time.
eCTD Regional Reference 2026
Sixteen regions side by side: Module 1 format, current specification, eCTD 4.0 position and the rules that cause rework.
Read and download →eCTD Pre-Submission Checklist
Thirty-five checks across envelope, documents, lifecycle, Module 1, study data, validation and transmission.
Get the checklist →Preventing Technical Rejection
How agencies validate, the nine defect categories behind rejection, and the practices that prevent them.
Read and download →eCTD 4.0 Readiness Guide
What changes from 3.2.2, where FDA, PMDA and others stand, and a readiness plan you can start now.
Read and download →For leaders, IT and quality.
Building a Regulatory Operations Function
What the function owns, how it differs from regulatory affairs, and what to put in place from first-in-human to commercial.
Read and download →Choosing Regulatory Software
A vendor-neutral capability map, RFP questions for regulatory, IT and quality evaluators, and a demo script.
Read and download →Validating a Cloud Regulatory Platform
Part 11, Annex 11 and CSA for SaaS: shared responsibility, vendor evidence and staying validated through releases.
Read and download →See what we build and how teams use it.
Product Brochures
Two pages each for DnXT Publisher, Reviewer, Planner and eDMS — what each does, who it is for and how it works.
Download →How Teams Use DnXT
Veeva Vault advisory, an on-premise to cloud migration, and an IND assembled from a client-reviewed plan.
Read the case studies →Compare DnXT
How DnXT compares with other approaches to regulatory publishing and information management.
See comparisons →AI in Regulatory Affairs
Our monthly webinar series on what AI means for regulatory professionals. Recordings on request.
See the series →Want to see it on your own submissions?
Bring a dossier you know well and we will walk it through DnXT end to end.
