Blogs
INSIGHTS & ARTICLES
DnXT Blog
Expert insights on regulatory operations, eCTD publishing, and digital transformation in life sciences.
AI in Regulatory Publishing: An Honest Comparison of Industry Approaches
A balanced analysis of how Veeva, Kivo, DnXT, and generic AI platforms approach AI in regulatory publishing — strengths and limitations of each.
Tenant Isolation in AI-Powered Regulatory Platforms: Why Architecture Matters
A technical breakdown of four-layer tenant isolation in DnXT's regulatory platform, and why it matters when AI agents interact with regulated data.
How We Built a 21 CFR Part 11 Audit Trail for AI-Initiated Actions
A technical look at how DnXT's audit trail infrastructure handles AI-initiated actions while maintaining 21 CFR Part 11 and ALCOA+ data integrity standards.
Open GxP: How MCP Is Connecting AI Agents to Regulatory Compliance Systems
How the Model Context Protocol enables AI agents to interact with GxP compliance systems while maintaining regulatory guardrails and audit integrity.
AI in Regulatory Affairs Is Not a Feature — It’s an Infrastructure Decision
Test excerpt update at 2026-04-10T23:20:09.336Z
The Hidden Cost of Disconnected Regulatory Systems — And What Integration Actually Looks Like
The Hidden Cost of Disconnected Regulatory Systems — And What Integration Actually Looks Like Walk into almost any mid-to-large pharma company’s regulatory department, and you’ll see a familiar sight: a...
We Built a Visual Workflow Engine for Pharma in 3 Weeks — Here’s the Architecture
We Built a Visual Workflow Engine for Pharma in 3 Weeks — Here’s the Architecture If you’ve spent any time in regulatory operations, you know the drill: critical processes like...
Why Health Authorities Are Watching How You Build Your eCTD — Not Just What You Submit
Why Health Authorities Are Watching How You Build Your eCTD — Not Just What You Submit If you’re still thinking of eCTD publishing as a “just make it valid” checkbox,...
From 5 Customers to 20+: What Scaling a Regulatory Tech Platform Actually Looks Like
From 5 Customers to 20+: What Scaling a Regulatory Tech Platform Actually Looks Like When we started DnXT, it wasn’t with a product in mind. It was with a deep...
Building an Enterprise AI Gateway for Pharma: Guardrails, Audit Trails, and Why “Just Use ChatGPT” Isn’t an Answer
Building an Enterprise AI Gateway for Pharma: Guardrails, Audit Trails, and Why “Just Use ChatGPT” Isn’t an Answer When we started building DnXT Solutions, our vision was clear: to bring...
Why I Rebuilt Our Entire Platform on Microservices — and What Breaking a Monolith Actually Looks Like
Why I Rebuilt Our Entire Platform on Microservices — and What Breaking a Monolith Actually Looks Like When we started DnXT Solutions, our goal was simple: build the best regulatory...
We Built a Three-Layer AI Classification System for Regulatory Documents — Here’s What We Learned
We Built a Three-Layer AI Classification System for Regulatory Documents — Here’s What We Learned If you’ve ever been part of a regulatory team, you know the drill: the frantic...
