Streamline the way you author and manage regulatory content with structured content authoring software for global pharmaceutical companies.
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.
Automate the repetitive, time-intensive steps in your authoring workflow – from cutting and pasting content, to rewriting approved language, to XML conversions.
ComplianceAuthor® AI automatically maps content into appropriate health authority formats. No coding necessary.
Using ComplianceAuthor® AI, authoring teams can significantly reduce the amount of time spent on the creation and management of regulatory documents.
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.
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.
Achieve quality excellence with structured data-driven methods and test specifications. Manage and reuse methods against test definitions to generate a consolidated report.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
You can book a demo with Glemser today!
