Regulatory Compliance

Increase Productivity. Reduce Costs. Enhance Regulatory Affairs.

Streamline your regulatory compliance systems and processes with our new end-to-end regulatory technologies, advisory and tech-enabled services. Free your team from labor-intensive tasks and maintenance to focus more on delivering valuable products to market.

Explore our comprehensive tech-enabled regulatory capabilities

GLOBAL REGULATORY AFFAIRS

End-to-end regulatory affairs and lifecycle management solutions.

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

IQVIA RIM SMART - REGULATORY INFORMATION MANAGEMENT

Intelligence, automation, integration.

Streamline your regulatory processes with our new, end-to-end regulatory information management system, IQVIA RIM Smart. Free your team from labor-intensive maintenance to focus on delivering valuable products to market.

IQVIA REGULATORY PRODUCTIVITY TOOLS

Boost your regulatory productivity.

Today’s stringent, global regulatory environment is exacting. And staying in compliance is an on-going, time-consuming series of activities. IQVIA Productivity Tools make it easy to rapidly prepare, publish and validate eCTD and non-eCTD electronic submissions to regulatory authorities, giving your regulatory staff valuable time back for higher-level activities.

IQVIA REGULATORY INTELLIGENCE

Stay up to date with changing regulatory requirements.

Keeping on top of regulatory requirements can be a challenge when they differ from country to country and are constantly changing. With IQVIA Regulatory Intelligence, you can access global regulatory information, ensuring you comply with confidence.

Regulatory compliance has long been viewed as a cost center and a necessity, but leading organizations are recognizing opportunities for innovation in this space.

Cynthia Verst, MS, PharmD President, Design & Delivery Innovation Research & Development Solutions

Reduce regulatory complexity, cost, and risk, across the entire regulatory lifecycle.

Our experienced 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 support, we’ve got you covered from early drug development through submissions and post-registration.

Affordably improve publishing and e-submission cycle times with IQVIA Regulatory Productivity Tools.

IQVIA’s new Regulatory Productivity Tools make authoring and PDF publishing fast and efficient. And our validation tool ensures that what you submit to regulatory authorities is in technical compliance prior to dispatch.

  • More easily prepare, publish, and validate eCTD and Non-eCTD electronic submissions
  • Increase efficiency and reduce associated infrastructure costs
  • Maximize throughput with intuitive, well-designed interfaces

With comprehensive RIM systems, companies gain much greater insight into their regulatory programs.

Michelle Gyzen, Sr Director
Integrated Global Compliance

RIM Smart – an intelligent, integrated approach to regulatory management.

RIM Smart is the modern regulatory information management solution built to increase speed, collaboration, efficiency and visibility across your entire global portfolio, improving performance at a lower cost.

Delivered securely in the cloud, IQVIA RIM Smart provides interconnected, comprehensive and intelligent management of the entire regulatory process.

Gain instant access to real-time regulatory updates

IQVIA Regulatory Intelligence provides instant access to regulatory insights and real-time updates from national authorities across the globe, helping you to avoid the resource-intensive process of gathering, organizing, and sharing important regulatory information.

  • Access to regulatory requirements for Human Drugs, Biologics, Medical Devices and IVDs
  • Access and compare requirements for over 110 countries, regions, and international organizations
  • Get notified on new or updated regulatory requirements
  • Determine the optimum regulatory pathway for new and existing drug products
  • Add internal company know-how, intelligence, and documents into the database
  • Access local expert insights through expert summaries
Go further with IQVIA Regulatory Compliance Solutions
Streamline your regulatory compliance systems and processes with our end-to-end regulatory technologies, advisory and tech-enabled services. Free your team from labor-intensive tasks and maintenance to focus more on delivering valuable products to market.
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