Document Hub
Centralized regulatory document management system that connects controlled content, document metadata, CTD authoring, review and approval workflows, version history, governance, reuse, and publishing across the regulatory lifecycle.
Transform Fragmented Documents into Controlled Regulatory Content
Regulatory teams often manage content across shared drives, email threads, disconnected repositories, and manual approvals, causing version-control issues, inconsistent metadata, limited traceability, and submission delays. RegX™ Document Hub unifies documents, workflows, collaboration, governance, visibility, and lifecycle history in one workspace
Regulatory Document Lifecycle Management Capabilities
Workflow Management
- Configurable author–reviewer–approver workflows
- Review, approval, and status management
- Role-based access and governance
- Version history and audit trails
Regulatory Content Management -- Modules 1–5
- Module 1: Regional administrative content
- Module 2: CTD summaries and overviews
- Module 3: Quality and CMC content
- Module 4: Nonclinical study reports
- Module 5: Clinical study reports
Centralized Regulatory Document Repository
- Secure and centralized document storage
- Role-based access controls
- Rapid document retrieval
- Relationships between documents and submissions
- Controlled archival and lifecycle maintenance
Document Metadata and Classification
- Document categorization and regulatory metadata
- Attribute-based classification
- Advanced search and filtering
- Predefined metadata attributes
- Improved document discoverability
- Controlled information governance
Content Authoring and Collaboration
- Controlled document creation and editing
- Regulatory team review and approval
- Content change tracking
- Consistent and accurate authoring
- Traceable lifecycle management
A Connected Document Lifecycle
Create
Develop regulatory documents within a controlled content environment.
Classify
Apply standardized metadata, document attributes, and regulatory classifications.
Review
Route content to assigned regulatory reviewers.
Approve
Capture controlled approvals, decisions, and document status changes.
Store
Maintain approved content in a secure, centralized repository.
Reuse
Identify and reuse approved content across products, programs, markets, and submissions.
Publish
Prepare controlled content for submission publishing and downstream regulatory processes.
Maintain
Manage revisions, relationships, version history, and lifecycle changes after approval.
Built on a Unified Regulatory Platform
RegX™ Document Hub connects document management with the broader RegX™ regulatory environment through:
Master data foundations
End-to-end content lifecycle management
Configurable workflows and automation
Security and access controls
Regulatory reporting and analytics
Business Value for Regulatory Organizations
Improved Operational Efficiency
Reduce time spent locating documents, managing email-based reviews, and reconciling multiple versions.
Stronger Regulatory Compliance
Apply controlled workflows, standardized metadata, role-based access, audit trails, and documented approvals.
Better Cross-Functional Collaboration
Connect regulatory, quality, clinical, nonclinical, safety, and CMC stakeholders within a shared content environment.
Consistent Content Management
Standardize how documents are created, classified, reviewed, approved, stored, and maintained.
Reduced Content Risk
Minimize the use of outdated, unapproved, incorrectly classified, or duplicated regulatory content.
Improved Data Integrity
Maintain reliable metadata, document relationships, version histories, and traceable regulatory records.
Strengthen Regulatory Content Management with RegX™
RegX™ Document Hub gives life sciences teams a secure and connected foundation for managing regulatory documents from creation through approval, reuse, publishing, submission, and ongoing maintenance.
Centralize controlled content, streamline collaboration, strengthen governance, and improve submission readiness with RegX™.