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Structured Content Authoring

RegX™ SPL Author enables life sciences organizations to create, validate, manage, reuse, and publish structured regulatory content across global markets. It transforms approved product information into submission-ready content while ensuring consistency, compliance, traceability, and efficient management of labeling and structured regulatory information. 

 
 
 
 
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From Manual Content Management toStructured Regulatory Publishing

Regulatory teams manage complex structured content requirements across regions, submission formats, and Health Authority standards. RegX™ SPL Author provides a unified workspace to create, validate, manage, reuse, and publish structured regulatory content while maintaining consistency, compliance, and lifecycle traceability. 

 

 
 
 
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Key Structured Content Authoring Capabilities

Structured Content Authoring
  • Create reusable structured content components 
  • Author content from approved sources and product data 
  • Support standardized templates and metadata 
  • Manage approved content components 
  • Reuse content across products and submissions 
  • Maintain metadata, taxonomy, and version control 
  • Manage review and approval workflows 
  • Maintain source-to-output traceability 
  • Support ongoing content maintenance 
Content Validation & Compliance
  • Validate content completeness and structure 
  • Apply regulatory standards and terminology requirements 
  • Perform consistency, traceability and submission checks 
  • Transform structured content into Health Authority-specific formats 
  • Support SPL, XML, Product Monograph, ePI, and other formats 
  • Maintain publishing consistency across markets and submission

Connected Structured Content Lifecycle

Create

Develop structured content components using approved regulatory information.

Validate

Verify content accuracy, completeness, structure, and compliance.

Approve

Enable controlled review and approval of regulatory content.

Manage

Maintain approved content, metadata, taxonomy, and lifecycle history.

Reuse

Provide actionable insights for regulatory teams and decision-makers.

Publish

Generate Health Authority-specific structured outputs.

Submit

Support regulatory submission processes with compliant content.

Maintain

Manage ongoing updates, changes, and lifecycle activities.

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Business Value

Faster Content Preparation

Accelerate structured content creation through reusable components and connected workflows.

Greater Content Reuse

Improve efficiency by reusing approved regulatory content across products and markets.

Improved Consistency

Maintain standardized regulatory content across submissions and publishing formats.

Stronger Compliance

Support regulatory requirements through validation, governance, and traceability.

Reduced Manual Effort

Minimize repetitive content preparation and maintenance activities.

Global Readiness

Enable structured regulatory publishing and submission support across worldwide markets.

Transform Structured Regulatory Content Management with RegX™

RegX™ SPL Author enables life sciences organizations to move from fragmented content processes to a connected structured content environment. By combining authoring, validation, reuse, publishing, and lifecycle management, RegX™ helps teams create consistent, compliant, and submission-ready regulatory content at scale. 

 

 

 
 
 
 
 
 
 
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