Transform regulatory submission workflows with one-click AI cover letter generation that ensures compliance while saving 95% of manual effort.
Transform regulatory operations with automated workflows connecting planning, document management, and eCTD publishing into seamless digital processes.
Regulatory submissions contain thousands of cross-references, internal links, and bookmarks. One broken link can trigger an agency refusal-to-file. Here’s how DNXT Publisher uses AI to eliminate that risk entirely.
EXTEDO eCTDmanager supports an extensive range of submission formats: eCTD v3, eCTD v4, NeeS, ACTD, eCopy, IMPD, PIP, VNeeS, DMF, ASMF, Clinical Trial Applications, and other regional formats including EAEU. This breadth is particularly valuable for organizations that submit to European health autho
eCTD 3.x: Uses a Document Type Definition (DTD) to define the XML backbone. The DTD specifies elements, attributes, and their relationships in a relatively rigid structure.
When Part 11 was written in 1997, enterprise software lived on servers in your data center. You controlled the hardware, the network, the backups, and the physical security. Compliance was complex but conceptually straightforward: you could point to the server room and say "our records are ther
Before diving into individual platforms, here's the framework regulatory teams should use when evaluating tools:
The Remote Revolution in Pharmaceutical Regulatory Affairs The pharmaceutical industry’s shift to distributed regulatory teams isn’t just a trend—it’s a strategic imperative. Companies managing remote regulatory operations are experiencing faster submission timelines, reduced overhead costs, and access to global talent pools that were previously out of reach. Yet many organizations struggle with the complexities of […]
The CFO Question Every Regulatory Leader Faces “How do you justify spending millions on regulatory technology when budgets are already stretched thin?” If you’ve been in pharma regulatory for more than five minutes, you’ve heard this question. The pressure is real – regulatory teams need modern document management solutions to stay competitive, but leadership demands […]
The Hidden Cost of Document Confusion Picture this: Your regulatory team is preparing for a critical FDA submission when someone discovers they’ve been working on an outdated document version for three weeks. Sound familiar? This nightmare scenario costs pharmaceutical companies millions in delays, rework, and compliance failures every year. In the high-stakes world of pharmaceutical […]
