Eliminate eCTD review fatigue with DnXT Reviewer. Fast navigation, side-by-side comparison, and collaborative annotations in one viewer.
Blogs
Move beyond compliance to strategic regulatory operations. Scalability, data quality, and submission intelligence insights.
How AI is transforming regulatory affairs from document management to intelligent compliance. Enterprise authoring and analysis at scale.
The Hidden Cost of Inefficient Regulatory Planning Every day pharmaceutical companies lose valuable time and resources to fragmented submission planning processes. Missed deadlines, disconnected teams, and manual tracking systems create bottlenecks that can delay critical drug approvals by months. The financial impact? Potentially millions in lost revenue and extended time-to-market. A Streamlined Solution Built for […]
How DnXT eliminates manual hyperlink creation in regulatory submissions. Automate link generation across your eCTD dossier.
The Tech Tsunami in Regulatory Ops: Are You Riding the Wave or Getting Swept Away? The world of regulatory operations is undergoing a massive transformation. We're talking about evolving tech, processes that actually talk to each other, and job roles that look nothing like they did five years ago. For anyone in life sciences, this shift [...]
eCTD 4.0 moves to HL7 RPS — a fundamental shift. Here’s what regulatory teams at emerging biotech need to prepare for and what to ask your vendor.
Enterprise RIM pricing goes far beyond the license fee. Here’s the full cost picture for growing biotech — and what to look for in alternatives.
Importance of a well built eCTD Reviewer The Best eCTD Viewing System to End Review Anxiety Are You Suffering from eCTD Review Fatigue? If your Regulatory Affairs team feels a constant knot of anxiety when facing a final submission, you're not alone. That sinking feeling—the result of slow software, cluttered interfaces, and the fear [...]
How DnXT transforms PDF rendering for regulatory publishing. Pixel-perfect compliance documents at scale, eliminating formatting issues and manual rework.
