ABOUT IQVIA SAFETY & REGULATORY COMPLIANCE
IQVIA Safety & Regulatory Compliance offers a complete lifecycle approach that brings together safety, regulatory, quality, and medical information to transform how life sciences companies sustain compliance and how compliance functions perform better together.
By integrating services, technology, and analytics, we can help bring together disparate compliance functions, resulting in heightened patient safety, improved compliance performance, and proactive insights power by IQVIA Connected Intelligence.
Click here to learn more about IQVIA Safety & Regulatory Compliance.
FEATURED SOLUTIONS
-
Regulatory Lifecycle Management (LCM) Services
Managing regulatory compliance for mature products while driving growth through new product development requires careful balance.
-
Safety And Regulatory Compliance Solutions
IQVIA offers a complete approach that combines safety, regulatory, quality, and medical information to transform and sustain compliance.
-
End-To-End Safety Solutions Designed For Success
As one of the world’s largest and most experienced safety and PV organizations, unearth how this provider is bringing extensive expertise and regulatory intelligence to every industry engagement.
-
IQVIA Regulatory Affairs And Drug Development Solutions
Discover how offering sponsors end-to-end strategic drug development and technology-enabled regulatory services helps to reduce time, cost, and risk, from discovery through post-registration.
-
Local Affiliate Product Services
Support your local safety needs and drive consistency with global requirements through end-to-end solutions with regulatory-focused medical experts and leading technologies.
-
Balancing Compliance Among The Shifting Sands Of Pharmaceutical Data Privacy Regulations
Maximize compliance, increase revenue potential, and improve patient safety by leveraging proven technology.
CONTACT INFORMATION
IQVIA Safety & Regulatory Compliance
IQVIA Innovation Park; 2400 Ellis Road
Durham, NC 27703
UNITED STATES
FEATURED CONTENT
-
Take an in-depth look and the challenges and benefits of incorporating AI solutions to enhance Medical Information (MI) services and the necessity of regulatory compliance.
-
Here, the authors explain why adherence to evolving requirements is essential for marketing-authorization holders (MAHs) to ensure compliance and maintain accurate product information.
-
To implement and leverage artificial intelligence and machine learning across the clinical trial lifecycle ethically, sustainably, and effectively, it is critical for developers and regulators to collaborate.
-
If you are unsure of how to navigate your post-approval regulatory journey, an experienced regulatory services partner can provide support to help you identify and achieve post-approval goals.
-
The pathway to enhancing reliability, compliance, and efficiency across lifecycle management will require embracing technology and process improvement if organizations want to achieve their goals.
-
Explore what the future of PV services and technology in the life sciences industry could look like if innovation, regulatory vigilance, and collaboration with regulatory bodies were prioritized.
-
As the Japan and Asia-Pacific region continues to grow as a hot spot for clinical research, pharma companies will need expert understanding of regulatory nuances to ensure compliance.
-
The introduction of artificial intelligence and machine learning into pharmacovigilance, safety, and regulatory workflows stands to have a major impact on process efficiency and employee workloads.
-
Delve into the challenges, objectives, solutions, and achievements of a regulatory review project undertaken by a mid-size pharmaceutical company across the European Union (EU), Asia-Pacific (APAC), Latin America (LATAM), and the Middle East.
-
See how transformative technologies like AI and ML augment the regulatory professional workload to ensure compliance, patient accessibility, and rapid timelines for approval for global drug campaigns.
-
In your search for an integrated safety partner, begin by assessing a vendor’s previous experience and whether their PV knowledge aligns with the needs of your product portfolio.
-
Learn how outsourcing local pharmacovigilance and medical information activities to an established safety organization can provide high-quality expertise and technology that meets demand.
-
Managing risks, time, effort, and costs while meeting regulatory demands can be overwhelming. Discover how blending human expertise with technology can increase efficiencies and reduce error.
-
No two journeys to drug approval look the same. That’s why it is critical to design a target product profile and regulatory approach to guide your program from the outset.
-
Learn how by having a strategy for “core-to-carton” compliance, drug developers can avoid risks for patients and their company.
-
A strong labeling team is vital to ensure successful navigation of the legal entity change process, including developing a timeline, executing data transfers, and mitigating compliance risks.
-
In complying with regulations, trial sponsors may need expert guidance on best practices for developing an EAC and overall strategy and oversight of key endpoint objectives and processes.
-
Managing local pharmacovigilance and medical information is no easy feat, but a local QPPV, a regulatory intelligence database, and innovative AI technology might be the solutions trials need.
-
Business continuity planning (BCP) ahead of the next pandemic or natural disaster is essential to ensure the success of any enterprise, but it's particularly crucial for companies in the life science industry.
-
Global biopharma companies are looking for ways to increase awareness and engage healthcare professionals seeking medical information. Explore why many see AI as a big part of the solution.