Discover how DNXT combines keyword search with AI-powered semantic understanding to help regulatory teams find documents instantly using natural language queries.
Discover how DNXT’s three-layer AI document classification system transforms eCTD regulatory submissions with 95-98% accuracy and 80-90% time reduction.
How DNXT built a centralized AI gateway with multi-provider routing, PII detection, and regulatory-grade audit trails for pharmaceutical compliance.
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
Before solving the scaling problem, it's worth understanding what sponsors evaluate when choosing a CRO for publishing services:
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:
Veeva does not publish list prices. All pricing is negotiated directly with Veeva's sales team, typically under NDA. However, industry analyses and user reports provide a reasonable picture of what companies actually pay.
