This on-demand webinar explores the essential alignment between regulatory affairs, process development, and manufacturing in biopharmaceutical commercialization. Our expert speakers discuss how integrating these functions ensures drug quality, safety, efficacy, and enables navigation of the complex regulatory landscape.
Gain insights into regulatory guidelines, with a focus on chemistry, manufacturing, and controls (CMC) documentation. Discover how effective regulatory affairs support can expedite global compliance and accelerate the commercial filing process.
Finally, discover how regulatory guidelines shape manufacturing processes, with practical insights on applying quality risk management, defining critical quality attributes (CQAs), and building robust control strategies that ensure consistent product quality from development through commercialization.
Listen to this webinar to understand how the synergy between regulatory and operational processes drives compliance, assures process control, and ultimately delivers high-quality products to market. This webinar draws attention to the commercialization of microbial bioprocesses, though the play-book that is presented can be applied also to other technologies in Lonza’s portfolio.