Explore our library of blogs, insights, research papers, and more information on compliance in the life sciences industry.
Compliance in 2024 is at a crossroads and life sciences companies are facing critical decisions that will shape their future direction in response to the evolving regulatory demands. Companies have had success in implementing the ‘7 Elements.’ However, very few have had success in developing an AI-driven compliance monitoring program. Advanced compliance monitoring in life […]
Meeting the federal and state aggregate spend reporting requirements demands significant time, resources, focus, and strategic processes from a life science organization. The evolving nature of the requirements and expectations set by the CMS make it extremely difficult for life science companies to comply with them, let alone monitor and stay updated with changes to […]
New policies, rules, and regulations followed by the dynamic nature of the life sciences industry make it much more overwhelming for compliance teams and companies to keep up with the evolving and heightened compliance demands, especially when you’ve chosen the wrong compliance partner to help you stay ahead of the game. Being considered one of […]
Mitigating compliance risks is important for life science companies. However, the pain of executing, measuring, and improving the effectiveness of a compliance program is well-known within the life science industry and by compliance teams. The highly scrutinized nature of the life science industry demands certain laws and regulations to be followed to avoid penalties and […]
A compliance program is an internal system or process composed of a set of rules, regulations, and guidelines created to enable life sciences to maintain legal, ethical, and professional operational standards while reducing the risk of breaching rules and regulations within the industry by following the laws issued by the Health & Human Services (HHS) […]
Compliance requirements can be difficult to abide by, but a strategic process consisting of the identification of risks, analysis, and remediation can play an essential role in enabling drug and device manufacturers to develop effective compliance programs. But before diving directly into the development phase, first and foremost comes the necessity of understanding the totality […]
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