IQVIA SmartSolve® has received the 2026 Frost & Sullivan Global Competitive Strategy Leadership Recognition in the AI-Enabled Quality and Regulatory Platforms for Life Sciences category. The recognition reflects SmartSolve’s approach to bringing quality, regulatory, data, and AI capabilities together in one platform built for life sciences.
For Quality Assurance and Regulatory Affairs teams, the need for a more connected approach is clear. A product change can affect registrations. A regulatory update can trigger changes to procedures, training, and documentation. A quality event may have implications across markets and throughout the product lifecycle.
Yet many teams still manage these activities across separate systems, spreadsheets, and manual handoffs. That makes it harder to see how one change affects another, identify risk early, and keep work moving across functions.
SmartSolve brings Quality Management System (QMS) and Regulatory Information Management (RIM) capabilities into a unified environment. Connecting these processes gives teams a more complete view of the information behind quality and regulatory decisions, while reducing the effort required to work across disparate systems.
SmartSolve helps pharmaceutical, medical device, and in vitro diagnostics organizations manage quality and compliance through more than 20 healthcare-focused modules spanning core quality, supplier management, premarket and post-market processes, and impact assessment. Its flexible, modular design enables organizations to start with the capabilities that matter most and expand as their needs evolve, while benefiting from a unified platform, a shared data foundation, and a consistent user experience.
AI is creating new possibilities for quality and regulatory operations, from finding information more quickly to supporting workflow automation and decision-making. In a regulated environment, however, usefulness is only part of the equation. Governance, traceability, auditability, privacy, and human oversight must be considered from the beginning.
IQVIA’s approach is to apply AI at the platform level with a human in the loop. SmartSolve includes traditional AI and generative AI capabilities and continues to evolve toward agentic AI designed for life sciences workflows. The focus is not AI for its own sake. It is using AI where it can reduce administrative effort, add capacity, and help teams work more effectively while supporting the controls expected in a GxP environment.
The value of connected quality and regulatory operations is best measured by what teams can accomplish.
One pharmaceutical and biologics quality leader shared:
“SmartSolve helped us cut the time required for document preparation and approvals by about 90%. What used to take days is now done in just a few clicks.”
Another customer described SmartSolve as establishing a standardized data foundation for future AI and analytics capabilities within a single digital QMS solution.
These examples speak to an issue many QARA teams know firsthand. Time spent searching for information, reconciling data, preparing documents, and moving work between systems is time that cannot be spent assessing risk, improving processes, or supporting product quality.
Sankara Narayanan, Industry Director at Frost & Sullivan, summarized the broader impact:
“IQVIA is improving both process and product quality, enhancing global healthcare. Through all its efforts, it empowers quality and regulatory teams to make a significant impact on their respective product lines and patient portfolios.”
This is SmartSolve’s seventh industry award in three years, adding to recognition for AI, healthcare technology, enabling technology leadership, customer value leadership, and innovation in quality and regulatory solutions.
Each award has focused on a different aspect of the platform, but together they reflect a consistent direction: quality and regulatory teams need technology that connects processes and information, applies innovation responsibly, and understands the requirements of life sciences.
The Frost & Sullivan recognition reinforces that direction. SmartSolve remains focused on helping QARA teams reduce fragmentation, respond to change with greater confidence, and make better-informed decisions across the product lifecycle.
Outdated compliance practices aren't viable amid evolving market and regulatory changes. IQVIA’s award-winning, end-to-end quality management system streamlines the product value chain, accelerates market entry, safeguards companies and patient safety, and meets complex regulatory demands.
SmartSolve® RIM manages regulatory submissions, product registrations, and health authority interactions.
AI‑enabled quality and regulatory compliance you can trust.
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