InSight RIM

Ennov InSight RIM is a powerful, end-to-end regulatory information management solution designed for life sciences organizations of all sizes — from startups to global enterprises. Shaped by over 20 years of customer feedback, it enables regulatory affairs teams to efficiently manage, analyze, and leverage regulatory data, streamlining processes, reducing time from study completion to submission, and accelerating treatment approvals. The platform supports the entire regulatory product lifecycle, from early planning of registration targets through to product retirement.

Without a robust RIM system, life sciences organizations risk noncompliance, operational inefficiencies, increased costs, and revenue loss from delays in getting treatments to market. Ennov InSight RIM addresses these challenges by providing a comprehensive, user-friendly platform built on a robust data model, with flexible APIs for seamless ecosystem integration and native connectivity with Microsoft Power BI for advanced analytics.

Core Capabilities

• End-to-end regulatory information management: Supports the full regulatory product lifecycle, including regulatory activity planning, product registration management, dossier creation, and dossier management.
• Dossier planning and submission tracking: Streamlines the planning and tracking of submissions, reducing time from study completion to regulatory submission.
• Comprehensive product and registration management: Manages product registrations across global markets, supporting compliance with international regulatory requirements.
• Fully compliant xEVMPD submissions: Enables organizations to meet xEVMPD submission requirements with confidence.
• Advanced analytics with Microsoft Power BI: Integrates natively with Power BI to transform regulatory data into valuable, actionable insights.
• Flexible APIs: Offers open APIs for seamless integration with existing regulatory and enterprise ecosystems.

Platform Features

• 100% web-based interface: Fully browser-based and highly scalable, with a user-centric design accessible to teams of any size.
• Enhanced data security: Single-tenancy architecture minimizes business interruptions, and data can be hosted locally for total flexibility.
• No IT skills required for configuration: System configuration and management are designed to make teams fully autonomous without reliance on IT resources.
• Part of the Ennov Regulatory Suite: Works alongside complementary products including Ennov Doc for Regulatory, Ennov Dossier, Ennov IDMP, DocShifter, and Ennov Artwork, providing a complete regulatory content and information management ecosystem.

Proven Customer Results

• Septodont, managing over 1,500 marketing authorization applications (MAAs) across 150 countries, was able to issue 400 dossiers in just 18 months using Ennov, with users experiencing significant time savings when locating documents.
• Aguettant highlighted Ennov's innovative spirit, ambition, and strong emphasis on customer user experience as key differentiators.
• Over 500,000 users across 450+ life sciences customers trust Ennov, with 98.5% of projects delivered on time and within budget.

Ennov InSight RIM is available as either a cloud-based or on-premises deployment, with the flexibility to switch between options at any time. The platform is ISO 9001 and ISO 27001 certified, supporting global regulatory compliance requirements and ensuring optimized performance and data security for life sciences organizations worldwide.