Assisted Content Authoring
AI-enabled regulatory content authoring solution that helps life sciences teams create, review, approve, reuse, update, and maintain submission-ready content within a governed environment.
From Fragmented Source Content toSubmission-Ready Documents
Regulatory authors navigate source documents, submissions, product data, Health Authority guidance, and disconnected repositories, increasing authoring time while limiting consistency, reuse, and traceability. RegX™ Assisted Author connects trusted sources, controlled AI-assisted authoring, templates, collaborative review, lifecycle management, and human approval.
Connected Capabilities for End-to-End Regulatory Authoring
AI-Assisted Content Authoring
- Generate content from trusted and approved sources
- Support document-, section-, and component-level authoring
- Apply governed generative and agentic AI capabilities
- Use controlled prompts and regulatory frameworks
Knowledge-Based Content Generation
- Approved source documents
- Previous regulatory submissions
- Controlled knowledge repositories
- Health Authority guidance
- Source-grounded generation with end-to-end traceability
Content Lifecycle Management
- Content updates and comparisons
- Regulatory impact assessment
- Reuse across products, markets, regions, and submissions
- Support for variations and supplements
- Support for Health Authority responses
- Ongoing maintenance of approved content
Structured Document and Section Authoring
- Author CTD and eCTD documents and sections
- Apply standardized templates
- Use predefined and embedded authoring prompts
- Maintain consistent document structures
- Support content across regulatory modules and document types
Review, Approval, and Collaboration
- Regulatory team collaboration
- Quality checks and content verification
- Controlled approvals
- Comment and issue management
- Traceable review and approval history
A Connected Regulatory Content Lifecycle
Source
Connect approved documents, regulatory submissions, knowledge repositories, guidance, and product information.
Generate
Create structured draft content using controlled prompts and approved knowledge sources.
Review
Perform regulatory, scientific and quality reviews.
Approve
Apply governed approval workflows before content is finalized or used.
Reuse
Reuse approved content across products, submissions, regions, and related regulatory activities.
Update
Compare versions, evaluate changes, and revise impacted content.
Publish
Prepare approved content for regulatory publishing and submission processes.
Maintain
Preserve content history, source relationships, approvals, and lifecycle traceability.
Powered by the Unified RegX™ Platform
Assisted Author works within the connected RegX™ regulatory environment, supported by:
Master Data Foundation
End-to-End Content LifeCycle
workflow & Automation
Security & Access Control
Regulatory analytics
Business Value for Regulatory Teams
Faster Content Development
Reduce time spent searching for source information, assembling initial drafts, and formatting repetitive regulatory content.
Reduced Manual Effort
Streamline document preparation, section development, source review, and content transformation.
Consistent Regulatory Content
Apply standardized templates, approved terminology, governed prompts, and reusable content across documents and submissions.
Improved Collaboration
Connect regulatory authors, quality reviewers, and approvers in a controlled workflow.
Greater Content Reuse
Reuse approved content across products, markets, submission types, and Health Authority responses.
Stronger Compliance and Traceability
Maintain source references, review history, approvals, content versions, and lifecycle records.
Transform Regulatory Content Authoring with RegX™
Move from fragmented source information and manual drafting to governed, traceable, and collaborative regulatory content development.
RegX™ Assisted Author helps teams create consistent, submission-ready content using trusted knowledge, structured authoring, controlled AI assistance, and mandatory human oversight.