Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
"We strive to help improve outcomes and create a healthier, more sustainable world for people everywhere.
LEARN MORE
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.
Research & Development Overview
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.
REAL WORLD EVIDENCE OVERVIEW
Elevate commercial models with precision and speed using AI-driven analytics and technology that illuminate hidden insights in data.
COMMERCIALIZATION OVERVIEW
Orchestrate your success across the complete compliance lifecycle with best-in-class services and solutions for safety, regulatory, quality and medical information.
COMPLIANCE OVERVIEW
When your destination is a healthier world, making intelligent connections between data, technology, and services is your roadmap.
TECHNOLOGIES OVERVIEWExplore our library of insights, thought leadership, and the latest topics & trends in healthcare.
DISCOVER INSIGHTSAn in-depth exploration of the global healthcare ecosystem with timely research, insightful analysis, and scientific expertise.
SEE LATEST REPORTS
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.
LEARN MORE
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.
LEARN MORE
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.
LEARN MORE
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.
LEARN MORE
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.
LEARN MORE
Empowering patients to personalize their healthcare and connecting them to caregivers has the potential to change the care delivery paradigm.
LEARN MOREOur mission is to accelerate innovation for a healthier world. Together, we can solve customer challenges and improve patient lives.
LEARN MORECareers, culture and everything in between. Find out what’s going on right here, right now.
LEARN MORE
"Improving human health requires brave thinkers who are willing to explore new ideas and build on successes. Unleash your potential with us.
SEARCH JOBSSo, your drug has reached the post-approval phase of its lifecycle, and you may be wondering, what comes next? Though the road to drug approval is long and rife with challenges, the post-approval phase comes with its own unique demands, including possible market expansion, evolving dosages and indications, and chemistry, manufacturing, and control (CMC) updates. Your team will need experts that can handle a wide variety of renewals and administrative tasks, especially if you are operating across multiple global jurisdictions. To start your journey successfully, familiarize yourself with what post-approval management demands. From there, assess what approach works best for your goals.
Proactive and effective lifecycle management will require either in-house or external experts that can handle the following tasks: renewals, CMC variations, labeling updates, regulatory information data management, and marketing authorization transfers and withdrawals. To work effectively with regulatory bodies, you will need to establish a thoughtful approach that entails the following:
Since the prospect of effective lifecycle management and regulatory strategy across multiple global jurisdictions can be daunting, many companies opt to work with a regulatory services provider as well as local qualified persons for pharmacovigilance (LQPPVs), who are now required in more than 40 countries.
A QPPV and LCM services provider can provide guidance in a variety of areas, including insight into market application expansion as well as end-to-end support for lifecycle management. Their team can also provide access to LQPPVs across multiple jurisdictions, and with access to a network of knowledgeable LQPPVs, your team can benefit from a variety of holistic solutions, including:
These benefits are only the beginning of what is possible when you partner with a qualified regulatory services provider and gain access to LQPPVs.
In a recent webinar, IQVIA experts, Vera Dinis, Regulatory Affairs Director, and Ana Pedro Jesuíno, Marketed Product Safety Associate Director, discussed their recommendations for navigating post-approval management, building an effective regulatory approach, and tackling post-approval regulatory obstacles, including divergent health authority expectations and supply chain disruptions. If you are looking for an effective map to traverse your drug’s post-approval lifecycle, download the full white paper, Effective Strategies for Post-approval Lifecycle Management and Local Pharmacovigilance.
Meet the challenge of changing stakeholder demands and increasing cost constraints with IQVIA's integrated technology services and analytics-driven offerings.
Automate and standardize your regulatory management, from correspondence and commitments to registration and tracking.
Harness the power of automation to execute streamlined end-to-end safety solutions while reducing costs.
Reimagine regulatory service delivery.
Harness the power of global human expertise combined with automation, artificial intelligence (AI) and machine learning (ML) to design, build and execute end-to-end safety solutions.
