Webinar: US Post-Approval Change Strategies for Small Molecules

In today’s evolving regulatory environment, timely and compliant execution of these changes is crucial for maintaining product integrity and avoiding costly delays. Whether you're navigating updates in formulation, manufacturing processes, or packaging, understanding how to properly characterize and file these changes with the FDA is essential to avoid delays, non-compliance, or product shortages.

Through a combination of real-world case studies and expert insights, we walk you through the steps required to assess proposed post-approval changes, streamline internal processes, and submit changes effectively to regulatory authorities with confidence. You'll gain valuable knowledge on how to handle urgent modifications while ensuring your regulatory filings are accurate, compliant, and timely.

Need help navigating post-approval changes in the US?

Contact us to see how we can support your team in all aspects related to regulatory strategies to move your product through all regulatory stages.