Global Regulatory Affairs Services
Reimagine regulatory service delivery.
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Americas
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Asia & Oceania
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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
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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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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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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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When your destination is a healthier world, making intelligent connections between data, technology, and services is your roadmap.
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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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"Improving human health requires brave thinkers who are willing to explore new ideas and build on successes. Unleash your potential with us.
SEARCH JOBSBlog
Move from Molecule-to-Market Seamlessly with Data-Driven Strategy
May 29, 2023
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A well-designed molecule-to-market plan starts in discovery and continues into lifecycle management. As you begin to navigate the wide and ever-evolving world of clinical development and drug regulation, you may find your team in need of guidance to help you identify the right indication to prioritize and build around. IQVIA’s Regulatory Affairs and Drug Development Solutions (RADDS) group provides multi-phase support to mitigate common roadblocks. Throughout your drug’s development cycle and beyond, RADDS provides a wide range of services, including: |
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- Recommending an indication to prioritize based on scientific, commercial, and operational data.
- Developing a target product profile and clinical development plan.
- Engaging with the Food & Drug Administration (FDA) during pre-investigational new drug (IND) meetings and subsequent IND submission.
- Conducting gap analysis to identify potential pitfalls.
- Leading dossier development and submission.
- Integrating technology to increase collaboration and transparency.
Use Proven Techniques to Design Effective Strategy
No two drugs follow identical pathways to the patients who need them. However, RADDS has established tried and true metrics that can help you assemble a path to market that aligns with your goals. RADDS helps customers move through the phases of product development, constructing action plans to answer the following questions (and more):
- What assets and indications should we prioritize?
- How do we build our target clinical and product profiles?
- What gaps exist in our clinical and nonclinical plans that need to be addressed prior to our first in-human studies (FIH)?
- How do we map out our clinical trials and what will be the associated time, cost, and risks to take us through registration?
- When should we file our IND?
- What special designations might our product be qualified for?
And the support doesn’t end once marketing authorization is achieved. To ensure continued safety and access for patients, RADDS provides customers with regulatory advice, market application expansion opportunities, and variation documentation.
Where Can I Learn More?
In a recent webinar hosted by RADDS team members, Michel Denarié, Senior Principal, and Michelle Gyzen, Senior Director, they illuminate how the RADDS team aids customers, breaking down the crucial steps needed at each phase of development. To learn more about the possibilities of partnering with RADDS on your drug’s journey to market, watch the on-demand webinar. To read a full summary and case study about a long-term RADDS partnership that led to cost savings and an expedited timeline, download the comprehensive whitepaper.
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