REGULATORY AFFAIRS AND DRUG DEVELOPMENT SOLUTIONS

End-to-end regulatory affairs and drug development

Providing you with regulatory, scientific, and medical advisory services supported by our data and technology, from early drug development through submissions and post‑registration.

REDUCE TIME, COST, AND RISK

Lower your administrative burden across the complete product lifecycle

Our Regulatory Affairs and Drug Development Solutions professionals help 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 from early drug development through submissions and post-registration. IQVIA’s regulatory, scientific, and medical advisory services 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

STRATEGIC DRUG DEVELOPMENT

Drive strategy through expert regulatory 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:

  • Indication Prioritization
  • Study design
  • Gap analysis
  • Regulatory program strategy
  • Innovative regulatory roadmaps

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
  • Specialty designations in areas such as orphan disease, regenerative medicine, advanced and breakthrough therapies, pediatrics, adaptive pathways, and more

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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