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Simplify Structured Content with
ComplianceAuthor® AI

Streamline the way you author and manage regulatory content with structured content authoring software for global pharmaceutical companies.

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Publish output
in any format
Improve time to
market with end-
to-end support
Perpetually sustain compliance with machine learning and automation

Trusted by Leading Authoring Teams


The AI-Powered Authoring Assistant

ComplianceAuthor® AI is a GxP-compliant, structured content management system that leverages natural language processing (NLP) and generative AI models trained on data behind your firewall to streamline your authoring process. All in a familiar, Word-based format.

  • Harmonize output-agnostic, component-based content with metadata / attributes / properties
  • Generate any health authority output or regulatory document type with omnichannel publishing
  • Access 30+ pre-configured submissions with industry relationships mapped, populated picklists, available drop-down menus
  • Support ecosystem of health authorities and local business operations for improved time-to-market
  • Maintain CFR Part 11 & EU Annex 11 compliance with audit trail and e-Signature capabilities out-of-the-box
Person with laptop representing automation and speed

Streamline component authoring for any submission

Automate the repetitive, time-intensive steps in your authoring workflow – from cutting and pasting content, to rewriting approved language, to XML conversions.

  • Microsoft Word-based authoring experience
  • Centralized component content management system
    (CCMS) cloud repository
  • Structured content management processes for tracking, managing, and reusing components

Automatically convert into any health authority output

ComplianceAuthor® AI automatically maps content into appropriate health authority formats. No coding necessary.

  • Automatic XML transformation
  • Life sciences compliance (CFR Part 11, EU Annex 11,
    e-Signatures, etc.)
  • Integrated health authority edits & feedback

Collaborate easier & shorten the document lifecycle

Using ComplianceAuthor® AI, authoring teams can significantly reduce the amount of time spent on the creation and management of regulatory documents.

  • Modular, componentized authoring & assembly
  • Granular integrations of authoring processes & data sources
  • Parallel review processes from inside MS Word with automatic merging of feedback

Enhance any regulatory document authoring workflow with generative AI

ComplianceAuthor® AI can be used to enhance authoring workflows for any kind of regulatory documentation or structured content process, including global drug labels , clinical labels, and product and test specifications.

Global Labeling

Say goodbye to endless rework and re-formatting. Access, update and reuse structured components for global labels in real-time and keep all your content organized, unified and compliant.

Clinical Labeling

End the chaos around regulatory compliance and inconsistent phrases. Easily manage your pre-approved terms and translated content and automatically generate clinical labels compliant with country-specific regulations.

Test specifications for CMC

Achieve quality excellence with structured data-driven methods and test specifications. Manage and reuse methods against test definitions to generate a consolidated report.

Cannabis labeling 

Revolutionize cannabis labeling by rapidly generating accurate labels, mitigating errors and maintaining consistency across diverse product lines, ultimately heightening the labeling process while ensuring consumer safety.

What users say about Compliance Author AI™


What users say about Compliance Author® AI

My company depends on Glemser to provide fast and accurate label support for our global product portfolio. We have been a long-time client and depend upon their staff to support our SPL requirements. Glemser manages all the details and communicates effectively with my team. They are easy to engage and keep us informed of any quality snags throughout the process.

Director, Global Labeling, Large Italian Pharma

Need help writing your regulatory content?

Need to streamline your authoring and management processes? We can help. Talk to one of our experts today or check out our on-demand SPL services.


What is ComplianceAuthor® AI?

ComplianceAuthor® AI is an advanced artificial intelligence tool designed to streamline the creation of accurate and compliant drug labels for pharmaceutical organizations. It leverages machine learning algorithms to analyze and interpret complex regulatory content, helping pharmaceutical organizations create and maintain compliant component-based content. 

How does ComplianceAuthor® AI work?

ComplianceAuthor® AI utilizes natural language processing (NLP) and machine learning to understand and interpret pharmaceutical regulatory texts. It aids in the accurate extraction of key information, ensuring that drug labels adhere to the latest regulatory standards and guidelines.

How does ComplianceAuthor® AI cater to the diverse needs of different use cases?

ComplianceAuthor® AI is tailored to address specific regulatory challenges in various use cases. For global labeling, it adapts to diverse linguistic and regional requirements, ensuring consistency while complying with international standards. In clinical labeling, it streamlines the creation process, aligning labels with evolving trial requirements. For CMC test specifications, ComplianceAuthor® AI automates the extraction of relevant information, facilitating efficient compliance. In cannabis labeling, the system is versatile, staying updated on evolving regulations to generate labels for medical products.

Does ComplianceAuthor® AI integrate with existing pharmaceutical compliance management systems?

Yes, ComplianceAuthor® AI is designed to seamlessly integrate with pharmaceutical compliance management systems. This ensures a cohesive workflow for organizations already using specific tools for managing and tracking pharmaceutical compliance.

Is ComplianceAuthor® AI customizable for different regions in pharmaceutical labeling?

Yes, ComplianceAuthor®AI is customizable to cater to the unique regulatory landscape of different regions, ensuring that pharmaceutical companies can comply with specific labeling requirements wherever they operate.

How does ComplianceAuthor® AI keep up with changes in regulations?

ComplianceAuthor® AI employs continuous learning mechanisms. It monitors regulatory updates and automatically adjusts its algorithms to reflect any changes. This proactive approach ensures that organizations are always aware of and compliant with the latest regulatory requirements.

Is ComplianceAuthor® AI suitable for organizations of all sizes?

Yes, ComplianceAuthor® AI is scalable and can be tailored to the needs of small businesses as well as large enterprises. Its flexible architecture allows organizations of all sizes to benefit from automated compliance management.

Can ComplianceAuthor® AI provide historical tracking of pharmaceutical labeling changes for auditing purposes?

Yes, ComplianceAuthor® AI offers historical tracking of pharmaceutical labeling changes, providing a comprehensive audit trail. This feature is valuable for audits, regulatory inspections, and maintaining a record of labeling modifications over time.

How does ComplianceAuthor® AI impact the labeling timeline and costs for organizations?

ComplianceAuthor® AI significantly accelerates labeling processes, providing an average reduction of 50% in the timeline required for labeling activities. Additionally, the implementation of ComplianceAuthor® AI results in substantial cost savings, with organizations experiencing an average reduction of 30% in labeling-related expenses.

How Can I See What ComplianceAuthor® AI looks like with my content?

You can book a demo with Glemser today!