Ennov RIM

Ennov RIM is regulatory information management software designed for Regulatory Affairs, Regulatory Operations, and registration teams in the life sciences industry. It centralizes product details, registrations, submissions, correspondence, and commitments in a single, structured system of record — eliminating the fragmentation caused by spreadsheets, shared drives, and disconnected tools. By connecting regulatory data with documents and dossiers, Ennov RIM reduces rework, improves data quality, and enables teams to answer business-critical questions faster and respond to health authority requests with greater confidence.

Built to support global portfolio oversight, Ennov RIM helps teams manage the full regulatory product lifecycle — from early registration planning through variations, launch activities, and ongoing lifecycle management. It supports both pharmaceuticals and medical devices, with configurable structures to match diverse portfolio needs.

Core Capabilities

• Centralized management of detailed product information across markets and product types
• Market authorization and registration management in a single system of record
• Submission and regulatory activity planning and tracking with clear ownership and deadlines
• Automatic linkage between substances, products, registrations, activities, dossiers, submissions, and documents
• Correspondence and commitment tracking connected to relevant products and registrations

Key Features

• Role-based access and action rights to control data visibility and process participation
• Configurable data model to reflect your organization's portfolio structure and SOPs
• Robust workflow engine with task routing, automated email notifications, and real-time status updates
• Intuitive, 100% web-based user interface accessible from anywhere
• 21 CFR Part 11 compliant to support regulated environments

Operational Efficiency and Workflow Automation

• Workflow-driven processes clarify what needs to be done, when, and by whom — reducing manual follow-up and keeping regulatory work on schedule
• Real-time status updates and notifications improve visibility into assignments and deadlines across teams
• Structured data entry and controlled processes reduce duplicate data entry and version conflicts
• Consistent, governed product data supports IDMP readiness as regulatory requirements evolve
• Fully compliant XEVMPD submissions are compiled, validated, and submitted directly through Ennov RIM, with integrated workflows to achieve and maintain compliance

Dashboards, Reporting, and Impact Analysis

• Out-of-the-box dashboards provide a portfolio-level view of workload, deadlines, and overdue activities across products and markets
• Regulatory Operations can monitor upcoming due dates, at-risk activities, and where follow-up is needed without pulling data from multiple sources
• Leadership dashboards track volume and timeliness of regulatory activities over time
• Impact analysis capabilities help teams understand which registrations may be affected by a change — such as a manufacturer update or formulation change — enabling faster, better-informed decision-making
• Specialized dashboards are available for use cases such as PSUR tracking and additional impact analysis views

Deployment and Platform

• Available as cloud-based or on-premises deployment, with the flexibility to switch between options at any time
• Single-tenancy architecture minimizes business interruptions, and data can be hosted locally for total flexibility
• System configuration and management require no IT skills, enabling teams to remain fully autonomous
• ISO 9001 and ISO 27001 certified, with improved security and optimized performance

Ennov RIM is part of Ennov's broader Regulatory Suite, which includes Ennov Doc for Regulatory, Ennov Dossier, Ennov IDMP, DocShifter, and Ennov Artwork — providing end-to-end support for regulatory content and information management across the product lifecycle. With over 25 years of experience serving 450+ life sciences customers and a 98.5% on-time, within-budget delivery record, Ennov brings proven expertise to regulatory information management.