SmartSolve RIM is an AI-enabled regulatory information management solution built on the SmartSolve® platform, purpose designed to support global registrations and regulatory operations. It centralizes regulatory information across products, markets, and health authorities, providing a single source of truth for regulatory teams.
By leveraging the SmartSolve platform’s proven architecture, SmartSolve RIM connects regulatory data across the product lifecycle, enabling greater visibility, reduced manual effort, and faster, more confident regulatory decision making in an increasingly complex global environment.
Ensure submission accuracy, consistency, and compliance across global markets for MedTech and Pharma.
SmartSolve RIM simplifies submission and publishing management for MedTech and Pharma organizations by centralizing regulatory data, content, and workflows in a single system. Regulatory teams can efficiently prepare, publish, and maintain submissions while ensuring alignment with market specific requirements.
Built to support complex and evolving global regulations, SmartSolve RIM reduces rework, improves consistency across submissions, and helps organizations meet regulatory timelines with greater confidence.
Maintain accurate product registrations across global markets for MedTech and Pharma.
Centralize and manage product registration data across regions in a single platform. SmartSolve RIM helps MedTech and Pharma teams organize registration details, track status and changes, and maintain compliance with evolving regulatory requirements, making it easier to manage global registrations efficiently and at scale.
Track and manage regulatory communications across global markets for MedTech and Pharma.
Centralize and organize all correspondence, commitments, and responses with global health authorities, including the FDA, EMA, and other regulatory agencies, within SmartSolve RIM. Gain full visibility into communication history and ensure timely, compliant responses throughout the regulatory lifecycle.
Centralize and control critical regulatory documents for MedTech and Pharma.
Manage regulatory content in a single, secure system to support streamlined document creation, review, approval, and ongoing compliance. SmartSolve RIM helps teams maintain version control, improve collaboration, and ensure documents are inspection ready across the regulatory lifecycle.
Ensure controlled, compliant change processes for MedTech and Pharma.
Manage changes with confidence, from simple document updates to complex, multi step initiatives involving new products, suppliers, or regulatory requirements. SmartSolve RIM helps MedTech and Pharma organizations define, track, and execute change plans with full visibility into actions, timelines, and supporting evidence, reducing risk and maintaining compliance across the regulatory lifecycle.
SmartSolve RIM is an AI-enabled regulatory information management solution built on the IQVIA SmartSolve platform that helps MedTech and Pharma organizations manage global registrations, compliance, and regulatory data.
It centralizes regulatory information across markets, supports inspection readiness, and enables faster, more confident regulatory decision making across the product lifecycle.
SmartSolve RIM is not a new product, but the next evolution of IQVIA’s regulatory solutions. It has been replatformed on Microsoft Azure and enhanced with AI capabilities to unify SmartSolve RIM and SmartSolve QMS on a single platform with a common data structure. This modernization delivers improved operational performance, integrated quality and regulatory workflows, and platform level AI, analytics, and connectivity to support global compliance and regulatory decision making.
SmartSolve RIM supports global compliance and audit readiness by unifying regulatory and quality workflows in a single, traceable system. It provides controlled content, up to date regulatory alerts, centralized lifecycle management, and full visibility into regulatory activities. This enables right first time submissions, strengthens audit readiness, and helps organizations maintain compliance across global markets.
SmartSolve RIM supports both MedTech and Pharma by combining industry specific workflows with a shared, configurable platform. At the workflow level, it provides tailored data structures, submission templates, and event management capabilities designed to meet the distinct regulatory requirements of MedTech and Pharmaceuticals. At the enterprise level, consolidated reporting and advanced analytics deliver transparency into performance, enabling consistent, enterprise wide decision making.
Whether supporting MedTech, Pharma, or both, SmartSolve RIM delivers a globally compliant solution that scales across industries while driving efficiency and regulatory consistency.
IQVIA SmartSolve® RIM was recognized by the Stevie Awards® for excellence in AI enabled regulatory information management, honoring innovation that drives global compliance and regulatory confidence.
A strategic white paper exploring how MedTech and Pharma organizations can accelerate global market access with greater regulatory confidence through connected, data driven regulatory processes.
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