Regulatory requirements and changes around the world bring new challenges
As pharmaceutical companies expand the number of regions within which they operate, whether related to clinical development, manufacturing processes, or product distribution it becomes increasingly complicated to address diverse regulatory requirements and manage changes.
Quality and regulatory functions are challenged by the expanding nature and variety of products (e.g., biologics, cell and gene therapies, companion diagnostics, delivery devices, digital health) as well as the depth and breadth of regulatory changes. Managing this diversity and change can be a strain on internal resources.
Because the task of changing standard operating procedures (SOPs) to comply with regulatory change in multiple regions is complex and time-consuming, industry leaders are looking to change the process completely. Ultimately, this will allow pharmaceutical companies to react to changes in regulatory requirements in a more proactive manner, preventing any possible compliance missteps.
This eBook will take a closer look at how AI and automation have the potential to streamline the maintenance of the regulatory lifecycle, particularly SOP monitoring, and updates.
Download the eBook to access detailed insights.