In this audiocast, the focus is on how Artificial Intelligence (AI) and Augmented Intelligence can impact the regulatory CMC strategies and submissions during drug development. The use of AI-based methods such as predictive analytics and machine learning can help in decision-making regarding quality control, reducing costs associated with corrective action plans, and identifying potential data requirement issues before they become serious problems. The audiocast also highlights an example of how an emerging biotech sponsor used AI-powered software to generate a CMC submission for a new drug candidate, saving time and reducing the risk of errors during the submission process. The audiocast concludes by emphasizing the importance of understanding the specific goals and objectives of the drug development process, selecting the right AI-powered tools, and having the right team in place to harness the power of AI to improve the regulatory CMC process.