SmartSolve RIM

SmartSolve RIM is a cloud-based regulatory information management platform developed by IQVIA, designed for life sciences organisations including pharmaceutical manufacturers, emerging biopharma, generics companies, and MedTech firms. It unifies regulatory submissions, registrations, and product lifecycle management within a single system, with the stated goal of accelerating global market access and reducing regulatory complexity.

The platform sits within IQVIA's broader Quality Management and Regulatory Suite, which combines AI-enabled quality management system (QMS) and RIM capabilities to support compliance, operational efficiency, and faster market access across the product lifecycle.

Core Capabilities

• Centralised management of regulatory submissions across global markets
• Registration tracking and lifecycle management for marketed products
• AI-enabled functionality to support compliance workflows and regulatory processes
• Integration within the IQVIA Quality Management and Regulatory Suite alongside SmartSolve eQMS
• Cloud-based deployment to support accessibility and scalability across organisations

Regulatory and Compliance Focus

• Supports regulatory compliance by blending technology with process management to reduce complexity, cost, and risk across the product lifecycle
• Designed to help organisations navigate global regulatory requirements and manage submissions to health authorities
• Part of IQVIA's integrated Safety and Regulatory Compliance offering, which also covers pharmacovigilance, quality compliance, medical information, and commercial compliance
• Positioned to support organisations in breaking down silos between quality and regulatory functions

Platform and Integration Context

• Delivered as a cloud-based solution, consistent with IQVIA's broader technology portfolio
• Operates within the IQVIA Technologies ecosystem, which incorporates AI and machine learning capabilities described as healthcare-grade AI
• Can be used alongside complementary IQVIA products including the IQVIA Vigilance Platform for pharmacovigilance and SmartSolve eQMS for quality management
• Supported by IQVIA's regulatory compliance services, which combine human expertise with technology to manage regulatory activities globally

SmartSolve RIM is part of IQVIA's integrated compliance portfolio, which spans safety, regulatory, quality, and medical information functions. It is available globally, with IQVIA operating across the Americas, Europe, Asia Pacific, and the Middle East and Africa regions.