IQVIA SmartSolve® RIM

Accelerate Global Market Access with AI-Enabled Regulatory Insights

Simplify compliance, speed up approvals, and stay audit-ready with SmartSolve RIM—the cloud-based platform built for MedTech, IVD, and Pharma leaders.

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Solutions Safety & Regulatory Compliance Quality Compliance SmartSolve® RIM

Streamline Global Compliance and Accelerate Market Access

SmartSolve RIM, built on the trusted SmartSolve® platform, is an AI-enabled, cloud-based solution for MedTech, IVD, and Pharma organizations. It unifies regulatory and quality workflows, automates compliance, and delivers real-time insights, so your team can move faster and with confidence. From creating regulatory content to managing global product registrations and lifecycle updates, SmartSolve RIM simplifies complexity and speeds approvals worldwide.

A quick, shareable overview of SmartSolve RIM’s capabilities and benefits.

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Why SmartSolve RIM?

SmartSolve RIM is simple enough to use, but it also has everything you need. It’s built around how publishers work, which makes a real difference in day‑to‑day publishing. We were able to get safety reports out in a matter of hours instead of waiting days with an outsourced vendor. It’s a huge return on investment.

Rich Fredericks

Senior Director - Regulatory, Quality & Clinical Solutions

End-to-End Regulatory Management

Submission & Publishing Management

Simplify global submissions and ensure compliance.

Accelerate market access with a single, integrated solution for planning, compiling, and dispatching regulatory submissions worldwide. SmartSolve RIM streamlines every step—from content creation to publishing—while supporting all major submission formats and providing real-time transparency, compliance, and efficiency for pharma and MedTech organizations.

Registration Management

Maintain accurate product registrations across markets.

Centralize and track product registration data for all regions in one platform. SmartSolve RIM helps you organize registration details, monitor status, and support compliance with evolving regulatory requirements—making it easier to manage global registrations efficiently.

Health Authority Interactions

Track and manage regulatory communications.

Centralize and organize all correspondence and commitments with global health authorities—such as the FDA, EMA, and other regulatory agencies—within SmartSolve RIM. Gain visibility into communication history and ensure timely, compliant responses throughout the regulatory process.

Document Management

Centralize and control critical regulatory documents—including content management for streamlined creation and approval.

Read the Content Management Fact Sheet

Change Management & Event Management

Ensure controlled, compliant change processes.

Manage every change with confidence—from simple document updates to complex, multi-step plans involving new products, suppliers, or regulatory requirements. SmartSolve RIM helps you define, track, and execute change plans with full visibility into actions, timelines, and evidence, ensuring compliance and reducing risk across your organization.

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Experience IQVIA SmartSolve RIM in action.

Discover how our AI-enabled regulatory platform simplifies global compliance, accelerates product approvals, and delivers real-time insights—all in one connected solution.

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SmartSolve RIM Frequently Asked Questions

SmartSolve RIM is an AI-enabled, cloud-based regulatory information management (RIM) platform that unifies global product registration, regulatory content authoring, submission management, and lifecycle activities. Purpose-built for MedTech and Pharma, it streamlines global compliance, improves audit readiness, and accelerates market access by integrating regulatory workflows with SmartSolve eQMS on a unified platform.

SmartSolve RIM represents the next evolution of IQVIA’s regulatory solutions—replatformed on Microsoft Azure and enhanced with AI capabilities. This strategic update unifies SmartSolve RIM and SmartSolve QMS on a single platform with a common data structure, delivering improved operational performance and integrated quality and regulatory workflows. Organizations can now leverage advanced AI features, analytics, and connectivity at the platform level to streamline global compliance and accelerate commercial success.

By unifying regulatory and quality workflows, SmartSolve RIM provides traceable records, controlled content, up-to-date regulatory alerts, and centralized lifecycle management. This ensures end-to-end visibility, supports right-first-time submissions, and strengthens audit readiness across global markets.

SmartSolve RIM and SmartSolve eQMS run on the same Azure-powered platform with a single data structure, enabling connected workflows across regulatory change management and quality execution. This closes the loop between regulatory requirements, controlled documents, CAPA, and training, improving audit readiness and reducing compliance risk.

At the workflow level, SmartSolve RIM provides tailored data structures, submission templates, and event management activities designed to address the unique requirements of MedTech and Pharmaceuticals. At the management level, consolidated reporting and advanced analytics deliver transparency into organizational performance and enable enterprise-wide decision-making. Whether supporting companies in MedTech, Pharma, or both, SmartSolve RIM offers a globally compliant, high-value solution that drives efficiency and compliance across the business.

Yes. IQVIA provides comprehensive migration support to help organizations transition from legacy RIM systems to SmartSolve RIM with minimal disruption. Our team offers data mapping, validation, and configuration services to ensure accuracy and compliance throughout the migration process. We also provide expert guidance, training, and best practices to accelerate adoption and reduce risk, so your organization can quickly leverage the benefits of an AI-enabled, cloud-based regulatory platform without compromising data integrity or compliance.

Yes, SmartSolve RIM is built on Microsoft Azure, delivering enterprise-grade security, scalability, and high availability. The platform is ISO 27001 and ISO 9001 certified and supports role-based access, data encryption, and alignment to GDPR and other data privacy regulations, making it suitable for regulated organizations.

IQVIA SmartSolve® RIM

Accelerate Global Market Access with AI-Enabled Regulatory Insights