In this episode, Anne and Kim discuss regulatory processes and submissions. They provide an overview of the CMC (Chemistry, Manufacturing, and Controls) template used in regulatory submissions. They also discuss the differences between brand new submissions and changes to existing submissions. The process of submitting changes for review and approval is explained, including the different types of changes and the expected timelines. Tips for successful submissions are shared, emphasizing the importance of providing the right level of information without overwhelming the submission. The episode concludes with an invitation for listeners to suggest specific topics or countries for future discussions.
