Reimagine regulatory service delivery

Staying on top of today’s complex, ever-changing regulatory demands requires a different approach. Expert resources. Streamlined processes. Leading technologies. A culture of partnering. IQVIA’s integrated team of Global Regulatory Affairs experts is designed to support your journey from early development through submissions and beyond.

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Lower your administrative burden across the complete product lifecycle

Our Global Regulatory Affairs team helps biopharma and medtech companies handle regulatory workflows more flexibly, productively and efficiently. From strategic regulatory advice to regulatory maintenance and lifecycle support, we’ve got you covered. IQVIA’s expert resources, streamlined processes and leading technologies provide:
  • Optimized time to key decision points
  • Regulatory and operational risk mitigation
  • Streamlined regulatory pathways
  • Flexible approaches to generating more informative evidence earlier
  • Improved transparency and proactive problem-solving

Drive strategy through expert insight and advice

Industry-leading therapeutic and functional area experts help clients glean relevant regulatory insights from world-class data, enabling real-time determination and evaluation of time, cost and risk. Our integrated consulting approach can also provide both program- and study-level strategy including realistic asset valuation. Learn more about our capabilities in

  • Gap analysis
  • Regulatory program strategy
  • Innovative regulatory roadmaps
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Keep your products on the right track

Navigate changing regulatory demands with greater accuracy, agility and efficiency. Let us help you where you need it most. Our 1900+ experienced regulatory affairs professionals stand ready to assist anywhere across the product lifecycle, in more than 65 global locations.

  • Health authority regulatory submissions - authoring and publishing across all drug development programs
  • US agency/health authority liaison on your behalf
  • Regulatory intelligence - real-time access to current requirements for 110+ countries and organizations
  • Lifecycle maintenance - license extensions, writing, labeling, marketing authorization transfers, CMC change requests
  • Specialty designations in areas such as orphan disease, regenerative medicine, advanced and breakthrough therapies, pediatrics, adaptive pathways, and more
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Streamline key workflows with tech-enabled services

Our worldwide hubs provide “follow-the-sun” submission management and publishing capabilities across the globe. Decades of experience managing electronic and paper dossiers assure speed, efficiency and quality at high volume.

  • Lifecycle publishing
  • Dispatch to health authorities
  • RIM data maintenance
  • Submission-ready document preparation
  • Technical formatting
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IQVIA RIM Smart - Regulatory Information Management

IQVIA RIM Smart. Intelligence, automation and integration.

IQVIA Regulatory Productivity Tools

Boost your regulatory productivity.

Regulatory Compliance

Automate and standardize your regulatory management, from correspondence and commitments to registration and tracking.

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