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Structured Content AI for Global Labeling

Reduce global product label generation time from months to days with an easy and cost-effective system your whole team will love. 

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Enhance global labeling workflow
with generative AI

ComplianceAuthor® AI simplifies your internal processes around authoring, reusing, translating, and managing product labels.

ComplianceAuthor® AI uses natural language processing specifically designed for pharmaceutical companies to index your existing clinical information into one controlled system.

ComplianceAuthor AI allows users easy and fast authoring through MS-Word. This provides companies with a powerful xml system in a simple Word interface.

ComplianceAuthor® AI helps users, health authorities and authorized third parties easily collaborate. Harmonize internal and external comments, edits, and tracked changes automatically in one document.

ComplianceAuthor® AI manages technical translations out of the box. ComplianceAuthor AI supports both in-house and third-party translation service providers.

ComplianceAuthor® AI leverages state of the art omni-channel publishing capabilities to automatically generate regulatory submissions like QRD, SPL, and FHIR formats.


Safely reduce label authoring timelines by up to 50%

Pharmaceutical labeling is a complex process involving multiple teams, all of them collaborating for months at a time on a single product. With ComplianceAuthor® AI, you can dramatically reduce the typical product label timeline while optimizing your processes and procedures.

Streamlined label authoring

Create and deploy structured content components across the globe. Make a change once, and gain insights to determine the next best action.

  • Cut your labeling process by up to 50%
  • Manage change control with tracking and compliance reporting
  • Facilitate instant feedback across teams

Outputs for every health authority

Experience seamless compatibility with all health authority outputs, ensuring your labels are ready for every market.

  • Generate traditional outputs like QRD and SPL
  • Supports emerging standards for data exchange like FHIR
  • Reuse components & translations across multiple labels
General Documents, US Documents and EU Documents
Data Manangement ComplianceAuthor Solutions

Works with your tech stack

ComplianceAuthor® AI integrates easily with your current systems in a way amplifies your capabilities.

  • Flexible system infrastructure designed to scale as your organization evolves
  • Leverage a secure cloud to organize and optimize your data supply chain
  • Minimize IT costs to support and maintain the system through the line of business

Built for component-based pharma content

ComplianceAuthor® AI enables the authoring, collaboration, and management of all your content at the component level for simple reuse and automatic impact analysis across your workflows.

Content analytics and change control

Search, find and index and monitor content. Manage change control across your enterprise, leveraging machine learning.

Structured product labeling

Design your product labels with regulated and compliant components at every stage of the drug’s lifecycle.

AI automated content generation

Use generative AI to transform internal data sheets into approved health authority labels, with a human in the loop.


Tools for the whole team

ComplianceAuthor® AI enables the authoring, collaboration, and management of all your content at the component level for simple reuse and automatic impact analysis across your workflows.
Familiar Microsoft Word interface
unstructured to structured data conversion
Life sciences capabilities (CFR Part 11, e-Signatures & more)
Automatic XML generation
Direct metadata tagging
Granular authoring process integrations
Collaborative review process
Automatic feedback merging
impact analysis for tracking changes to components
Integrates with other solutions (Veeva, Documentum, Sharepoint)
Pre-configured outputs & picklists

See how your labeling process can be improved with ComplianceAuthor® AI