Regulatory Insights
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Efficiency & Quality: The Impact Of CDASH eCRFS On Clinical Trials
7/16/2024
Discover how CDASH eCRFs are transforming clinical trials, enhancing efficiency and quality through validated standards and streamlined data collection, benefiting both study designers and participants.
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Reporting To The IRB: Unanticipated Device Effects In Medical Device Studies
7/16/2024
Explore key differences in regulatory requirements for medical device studies compared to drug trials, and learn why understanding the unique term UADE is crucial for compliance and safety.
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The Regulatory Binder Checklist For Clinical Trial Sites
7/16/2024
By following this checklist, research teams can enhance organizational efficiency, maintain compliance with regulatory standards, and confidently navigate the complexities of documentation management.
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Making Global Reliance A Reality For Post-Approval Changes Of Medicines And Vaccines
7/16/2024
Discover how global stakeholders are working together to streamline regulatory processes and enhance transparency through reliance approaches in post-approval changes (PACs).
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FDA Pathways To Medical Device Approval
7/16/2024
Explore the diverse pathways available for bringing your medical device to market in the U.S. to ensure you select the optimal route for FDA approval or clearance.
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From Idea To Market: The Five Stages of Product Development
7/16/2024
Discover the essential regulatory pathways and requirements for developing and distributing medical devices in the United States to ensure compliance and successful market entry.
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Deciphering The FDA's Diversity Plan Updated Guidance
7/16/2024
Updated FDA guidance from June outlines the format and content of Diversity Action Plans, the products and studies requiring a plan, and the submission process. Learn about the changes and what to expect.
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Navigating Regulatory Compliance Activity: Are You Prepared?
7/15/2024
Examine the COVID-19-driven shifts in regulatory compliance and facility oversight to understand their impact on medical product supply chains and the need for proactive compliance.
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Maximize The Efficiency Of Regulatory Operations With 5 Key Competencies
7/15/2024
Gain insight into how the pharmaceutical industry can manage the dual demands of advancing drug development while supporting revenue-generating mature products through streamlined regulatory maintenance.
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Strategies For Post-Approval Lifecycle Management And Local PV
7/12/2024
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.