Automated Assembly
Drag-and-drop dossier building with intelligent document ordering and lifecycle management
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DnXT Publisher
Smarter, Faster eCTD Publishing
Transform complex dossier assembly into a streamlined, automated process. DnXT Publisher delivers compliant, submission-ready eCTD packages with real-time validation, automated metadata management, and direct DMS integration — so your team can focus on strategy, not formatting.
DMS Integration
Seamless connection to Veeva Vault, SharePoint, and other document management systems
Real-Time Validation
Catch errors before submission with built-in eCTD validation against all regional specifications
Multi-Region Support
Publish to FDA, EMA, Health Canada, TGA, and more from a single platform
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DnXT Reviewer
Redefining eCTD Review Excellence
Navigate complex eCTD submissions with an intuitive, cloud-native review experience. Compare sequences in seconds, collaborate securely across teams, and maintain complete audit trails — all within a single, unified platform built for regulatory professionals.
Lifecycle Tracking
Intelligent eCTD viewing with full lifecycle history and cross-reference navigation
Secure Collaboration
Annotation, comments, and review workflows with role-based access control
Sequence Comparison
Rapid side-by-side comparison of submission sequences with change highlighting
Labeling Comparison
Direct comparison of labeling content across previous lifecycles for faster QC
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DnXT RIM Suite
Regulatory as a Strategic Capability
A comprehensive Regulatory Information Management suite that treats regulatory operations as a strategic asset, not administrative overhead. Plan submissions, track registrations, manage correspondence, and orchestrate your entire regulatory lifecycle from a single command center.
Submission Planning
Visual timeline management with milestone tracking, dependencies, and agency deadline monitoring
Correspondence Management
Centralized tracking of agency communications with automated response workflows
Registration Tracking
Global registration status dashboard with country-level visibility and renewal alerts
Marketplace Integration
Seamlessly connect with CROs, affiliates, and external partners for controlled outsourcing
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DnXT AI
Intelligence That Understands Regulation
Purpose-built AI that seamlessly integrates into every stage of the regulatory lifecycle. From automated document classification and real-time validation to predictive compliance alerts and contextual review assistance — DnXT AI transforms manual effort into digital intelligence.
Document Classification
AI-driven tagging, metadata extraction, and automatic CTD section mapping
Compliance Prediction
Early alerts on regulatory changes, risk impacts, and potential submission gaps
Content Summarization
Contextual summaries of submission documents and sequence changes for faster review
Correspondence Analysis
Automated parsing and classification of agency correspondence with action item extraction
Platform Capabilities
Explore Every Feature of DNXT Publisher Suite
Each capability is built for regulatory teams who need speed, compliance, and control — from first draft to agency submission.
eCTD Publishing
3.x and 4.0 support with automated assembly and multi-region compliance.
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AI Document Intelligence
Automated classification, metadata extraction, and contextual review.
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Multi-Regional Compliance
Publish to FDA, EMA, Health Canada, TGA and more from one platform.
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Preflight & Validation
Catch errors before submission with real-time eCTD validation.
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Dossier Cloning
Lifecycle management with intelligent dossier cloning and versioning.
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PDF Workbench
Integrated viewer, bookmark management, and hyperlink automation.
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Enterprise AI Gateway
Secure, governed AI with private model routing and audit trails.
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Veeva Vault & DMS
Native integration with Veeva Vault, SharePoint, and major DMS platforms.
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Unified Search
Cross-dossier search and discovery across submissions and documents.
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Enterprise Security & SSO
SAML SSO, role-based access, 21 CFR Part 11, and SOC 2 compliance.
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