Regulatory Intelligence

Regulatory Intelligence is a solution from ArisGlobal, part of the LifeSphere platform, designed for life sciences companies, CROs, and regulatory affairs teams that need to monitor regulatory updates and maintain consistent compliance. The tool uses GenAI automation, powered by ArisGlobal's NavaX engine, to automatically track regulatory changes and build a centralized knowledgebase accessible across the organization.

The solution is intended to reduce the manual effort involved in regulatory monitoring, giving teams more time for higher-value work while ensuring they remain current with the latest regulatory requirements and changes. ArisGlobal works with more than 220 global life sciences companies and government health authorities, including the FDA, Health Canada, and NMPA.

Core Capabilities

• Regulatory Monitoring: Automatically monitors predefined online sources for new regulatory changes, removing the need for manual tracking.
• Repository Updates: Automatically downloads and classifies identified regulatory updates into a centralized repository.
• Impact Assessment: Performs impact assessment on regulatory records to help teams understand how changes affect their registrations.
• Knowledgebase Querying: Supports flexible searching and filtering of repository resources to locate relevant regulatory information.
• Advanced Cognition: Provides conversational information discovery through a chatbot interface, enabling users to query the knowledgebase using natural language.
• Advanced Automation: Leverages NavaX GenAI automation to deliver up-to-date insights across regulatory monitoring and compliance workflows.

Key Benefits

• Time savings: Eliminates manual monitoring tasks, allowing regulatory affairs staff to focus on value-adding activities.
• Single source of information: Establishes a centralized repository for regulatory intelligence that is readily accessible by the team.
• Streamlined compliance: Keeps organizations up to date on the latest regulatory requirements and changes.
• Advanced insights: Uses NavaX automation to provide robust, current insights including registration impact assessments.

Platform and Company Context

• Regulatory Intelligence is part of ArisGlobal's LifeSphere technology platform, which serves the broader life sciences industry across drug development, safety monitoring, and regulatory compliance.
• ArisGlobal is headquartered in the United States with regional offices in Europe, India, Japan, and China.
• The NavaX automation engine underpins the GenAI capabilities within the solution.