Features

PLATFORM CAPABILITIES

DNXT Publisher Features

Enterprise-grade tools for regulatory document management, built for life sciences teams that demand compliance, speed, and reliability.

21 CFR Part 11 compliant audit trail with electronic signatures, full document history, and tamper-proof logging for every action.

Automate review cycles, approvals, and routing with configurable workflows that eliminate manual handoffs and bottlenecks.

SOC 2 Type II certified with AES-256 encryption, role-based access controls, SSO/SAML, and custom data residency options.

Complete data isolation for CROs and enterprise teams. Each client gets their own secure environment with independent configurations.

Full eCTD 3.x and 4.0 publishing with multi-regional support — US FDA, ICH, Health Canada, SAHPRA, and GCC from a single dossier.

Auto-link cross-references, generate bookmark suggestions, and run semantic search — powered by Azure OpenAI, Claude, and GPT-4.

One dossier, five regions. Region-specific TOC templates, module 1 handlers, and validation rules applied automatically per jurisdiction.

Automated pre-submission checks across PDF compliance, XML schemas, folder structure, and hyperlinks — with auto-fix for common issues.

Clone full regulatory dossiers with smart hyperlink cleanup, eCTD 4.0 conversion, and regional metadata adaptation in one click.

Browser-based PDF viewer with bookmark editor, AI bookmark advisor, hyperlink detection, and link accept/reject workflow.

Multi-provider AI (OpenAI, Claude, Vertex AI) with per-tenant config, PII detection, rate limiting, and a full 21 CFR Part 11 audit trail.

Bi-directional Veeva Vault sync plus Documentum, Box, Egnyte, and Google Drive — connect without migrating your documents.

Full-text Lucene search plus AI semantic RAG search across all dossiers, documents, metadata, and TOC nodes in a single query.

Azure AD and Okta SSO, RBAC, multi-tenant isolation, 21 CFR Part 11 audit trail, and CSRF/XSS protection throughout.