RIM

ArisGlobal's Regulatory Information Management (RIM) is a module within the LifeSphere platform designed for life sciences companies managing regulatory planning, tracking, and registration activities across global markets. It is intended for biopharmaceutical firms, CROs, and other life sciences organizations that need to coordinate regulatory submissions and registrations throughout the product lifecycle. ArisGlobal works with more than 220 global life sciences companies and government health authorities, including the FDA, Health Canada, and NMPA.

RIM reduces data entry requirements, improves data quality, and increases global oversight by providing a centralized system for managing regulatory planning, tracking, and registration records. It supports investigational and marketed drug and medicinal products, active substances, devices, and site registrations.

Core Capabilities

• Regulatory Planning and Tracking: Built-in support for planning submissions and tracking registrations, correspondence, commitments, and other key regulatory information.
• Connectivity and Automation: Works across documents, submissions, interactions, labeling, product data, and regulatory intelligence within a connected workflow.
• Global Coverage: Centralizes global submission planning and tracking across all markets.
• Localized Support: Accommodates specific regional requirements and regulatory knowledge for national-level activities.
• IDMP Compliance: Supports the IDMP target operating model.
• Interactive Dashboards: Provides actionable insights into regulatory activities and registrations.

Key Operational Benefits

• Standardized Processes: Supports more consistent end-to-end workflows for regulatory planning and tracking across all markets, reducing time and effort.
• Enhanced Collaboration: Facilitates teamwork among various stakeholders at both global and national levels.
• Single Source of Truth: Establishes a centralized area for worldwide registration activities and records, reducing data silos.
• Product Specifics: Covers investigational and marketed drug and medicinal products, active substances, devices, and site registrations.

AI-Powered Enhancements

• Health Authority Interactions (GenAI): Automates the intake and management of health authority communications.
• Regulatory Intelligence (GenAI): Supports compliance through enhanced regulatory insights.
• Intelligence Agents (Agentic AI): Applies autonomous intelligence to regulatory quality and compliance tasks via NavaX Agents for Regulatory.

LifeSphere RIM is developed by ArisGlobal, which is headquartered in the United States with regional offices in Europe, India, Japan, and China. The platform is positioned as part of a broader LifeSphere regulatory technology suite that spans the full regulatory lifecycle.