Test excerpt update at 2026-04-10T23:20:09.336Z
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 collection of best-of-breed systems, each designed to do one thing well, but rarely speaking to each other. It’s a landscape I’ve navigated countless times in […]
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 document reviews, submission approvals, and safety report routing often live in a chaotic mix of email chains, shared drives, and manual follow-ups. Or, if you’re […]
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, you’re missing a critical shift in health authority expectations. The days of agencies simply validating your XML against a DTD and moving on are rapidly […]
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 understanding of regulatory operations, honed through years of consulting with global pharma companies, helping them navigate complex Veeva Vault implementations and optimize their processes. What […]
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 cutting-edge technology to life sciences regulatory operations, making complex processes simpler, faster, and more compliant. For years, we’ve delivered on that promise, and frankly, the […]
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 operations platform for life sciences. Like many startups, we began with what was practical and fast. Our first iteration was a classic monolith: a robust […]
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 rush to assemble a submission, the mountains of documents, and the painstaking, often soul-crushing task of manually classifying each one into its correct eCTD module […]
Beyond Controlled Vocabulary: The Case for Regulatory Reasoning For decades, our industry has grappled with the challenge of consistent, compliant data. The solution, for a long time, was the controlled vocabulary. And don’t get me wrong, it was a massive leap forward. Before controlled vocabulary, we faced metadata chaos – free-text fields, endless variations for […]
Why Your Veeva Vault Implementation Needs a Consulting Partner (Not Just a Configurator) I’ve been in the trenches of regulatory operations and technology for decades. I’ve seen companies invest millions in systems like Veeva Vault, only to find themselves struggling months or a year after go-live. The system is there, it’s technically functional, but it’s […]
