GLOBAL REGULATORY AFFAIRS

End-to-end regulatory affairs, operations, and lifecycle management.

Providing you with regulatory strategy, labeling, publishing, and intelligence solutions supported by our global expertise, data and technology, from early drug development through submissions and post-registration. 

REDUCE REGULATORY COMPLEXITY, COST, AND RISK

Lower your regulatory burden across the complete product lifecycle

Our Regulatory Affairs professionals help biopharma and MedTech companies handle regulatory workflows more flexibly, productively, and efficiently. From strategic regulatory advice to regulatory maintenance and lifecycle management, we’ve got you covered from early drug development through submissions and post-registration. IQVIA’s regulatory strategy, labeling, publishing, and intelligence solutions provide:

  • Fact-based decisions that improve probability of success and regulatory approval
  • Regulatory and operational risk mitigation
  • Streamlined regulatory pathways
  • Flexible approaches to generating more informative evidence earlier
  • Improved transparency and proactive problem-solving

END-TO-END REGULATORY SUPPORT

Regulatory guidance along the drug development continuum

Navigate changing regulatory demands with greater accuracy, agility and efficiency. Let us help you where you need it most. Our 3,300+ 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
  • Flexible regulatory technology supports your technology, IQVIA RIM Smart, or a customized hybrid solution to support your business objectives

TECHNOLOGY-ENABLED REGULATORY SOLUTIONS

Streamline key workflows with tech-enabled regulatory services

Advances in artificial intelligence (AI) and machine learning (ML) have long helped other industries. Now it is happening in healthcare. By leveraging deep scientific and health system expertise, IQVIA provides technology-enabled solutions, from site selection through post-launch safety, and can also help you respond in near real-time to regulators as well as payer and provider demands for evidence. That’s the power of analytics and data structured for the distinct needs of your organization.

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