Regulatory Compliance
Automate and standardize your regulatory management, from correspondence and commitments to registration and tracking.
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Americas
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Asia & Oceania
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A-I
J-Z
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Middle East & Africa
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Regions
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Americas
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Asia & Oceania
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Europe
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Middle East & Africa
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Americas
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Asia & Oceania
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Europe
Europe
- Adriatic
- Belgium
- Bulgaria
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- Deutschland
- España
- France
- Greece
- Hungary
- Ireland
- Israel
- Italia
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more -
Middle East & Africa
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
SOLUTIONS
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Research & Development
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Real World Evidence
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Commercialization
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Safety & Regulatory Compliance
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Technologies
LIFE SCIENCE SEGMENTS
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Impacting People's Lives
"We strive to help improve outcomes and create a healthier, more sustainable world for people everywhere.
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Harness the power to transform clinical development
Reimagine clinical development by intelligently connecting data, technology, and analytics to optimize your trials. The result? Faster decision making and reduced risk so you can deliver life-changing therapies faster.
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Real World Evidence. Real Confidence. Real Results.
Generate and disseminate evidence that answers crucial clinical, regulatory and commercial questions, enabling you to drive smarter decisions and meet your stakeholder needs with confidence.
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See markets more clearly. Opportunities more often.
Elevate commercial models with precision and speed using AI-driven analytics and technology that illuminate hidden insights in data.
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Service driven. Tech-enabled. Integrated compliance.
Orchestrate your success across the complete compliance lifecycle with best-in-class services and solutions for safety, regulatory, quality and medical information.
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Intelligence that transforms life sciences end-to-end.
When your destination is a healthier world, making intelligent connections between data, technology, and services is your roadmap.
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BLOGS, WHITE PAPERS & CASE STUDIES
Explore our library of insights, thought leadership, and the latest topics & trends in healthcare.
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WHO WE ARE
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NEWS & RESOURCES
Unlock your potential to drive healthcare forward
By making intelligent connections between your needs, our capabilities, and the healthcare ecosystem, we can help you be more agile, accelerate results, and improve patient outcomes.
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IQVIA AI is Healthcare-grade AI
Building on a rich history of developing AI for healthcare, IQVIA AI connects the right data, technology, and expertise to address the unique needs of healthcare. It's what we call Healthcare-grade AI.
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Your healthcare data deserves more than just a cloud.
The IQVIA Human Data Science Cloud is our unique capability designed to enable healthcare-grade analytics, tools, and data management solutions to deliver fit-for-purpose global data at scale.
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Innovations make an impact when bold ideas meet powerful partnerships
The IQVIA Innovation Hub connects start-ups with the extensive IQVIA network of assets, resources, clients, and partners. Together, we can help lead the future of healthcare with the extensive IQVIA network of assets, resources, clients, and partners.
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Proven, faster DCT solutions
IQVIA Decentralized Trials deliver purpose-built clinical services and technologies that engage the right patients wherever they are. Our hybrid and fully virtual solutions have been used more than any others.
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IQVIA Patient Experience Solutions powered by Apple
Empowering patients to personalize their healthcare and connecting them to caregivers has the potential to change the care delivery paradigm. IQVIA and Apple are collaborating to bring this exciting future of personalized care directly to devices patients already have and use.
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Our mission is to accelerate innovation for a healthier world. Together, we can solve customer challenges and improve patient lives.
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Careers, culture and everything in between. Find out what’s going on right here, right now.
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WE’RE HIRING
"Improving human health requires brave thinkers who are willing to explore new ideas and build on successes. Unleash your potential with us.
SEARCH JOBSWhite Paper
Unlocking Regulatory Complexities
The key to combination product success
Feb 01, 2019
This white paper explores medical device combination product strategies to improve the regulatory journey from classification to market clearance for sponsors. The shifting borders among traditional drugs, biologics, and medical devices are poised to produce safer and more effective combination products that offer new diagnostic and treatment options for patients.
These products consist of two regulated components, a drug and a medical device, which are combined to develop a single product. But such novel combination products pose numerous regulatory hurdles for sponsors, even when comprised of previously cleared components. Drug-device combination products are notably complex, particularly when it comes to designing clinical trials and preparing for regulatory review. Partnering with a contract research organization (CRO) with experience in planning and executing both medical device and drug trials can help sponsors navigate these hurdles.
This paper explores medical device combination product strategies IQVIA™ recommends to improve the regulatory journey from classification to market clearance for sponsors.
A growing market
The commercial market for drug-device combination products is expected to grow at a compound annual growth rate of more than 11 percent by 2019.1 There are a number of drivers behind this growth, primarily an emergent patient population with chronic diseases such as cardiovascular disease, diabetes, prostate cancer and others. Demand for minimally invasive surgeries and portable devices, such as inhalers and insulin injectors, is also fueling growth.
For regulatory purposes, the U.S. Food and Drug Administration (FDA) defines combination products as therapeutic and diagnostic products that combine drugs, devices or biological products.2 Many other regulatory authorities ranging from Japan’s Pharmaceuticals and Medical Device Agency (PMDA) and China’s State Food and Drug Administration (SFDA) to Canada’s Health Authority (Health Canada) and the European Medicines Agency (EMA) review and approve combination products via processes that differ from the FDA and from each other, even within EU member countries. While this paper focuses on the FDA requirements for combination products, IQVIA can provide counsel regarding the requirements crucial to clinical evaluations and timely market clearance globally.
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