Comprehensive enterprise security framework protecting pharmaceutical regulatory data with Azure AD authentication, encrypted credentials, and complete 21 CFR Part 11 audit trails.
Transform regulatory submission workflows with one-click AI cover letter generation that ensures compliance while saving 95% of manual effort.
Discover how AI-powered EDMS features transform pharmaceutical document management with intelligent duplicate detection, automated summarization, and smart classification for faster regulatory submissions.
Transform regulatory operations with automated workflows connecting planning, document management, and eCTD publishing into seamless digital processes.
DNXT validates every PDF against 23 compliance rules for FDA EMA submissions, eliminating technical rejections with automated validation and auto-fix capabilities.
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
