This live webinar delves into the complex world of New Drug Applications (NDA) and Biologics License Applications (BLA), shedding light on the crucial regulatory processes that pharmaceutical companies must follow for the approval of new drugs and biologics and aims to empower participants with the knowledge and tools needed to navigate the NDA/BLA journey.
Join us to witness our experts discuss successful planning strategies for an original NDA/BLA submission. Our regulatory strategy, regulatory operations and program leadership experts will share key learnings from recent NDA/BLA submissions as well as some essential tools and workstreams that continually enable our clients to execute successful NDA/BLA submissions. Topics from identifying the trigger at which NDA/BLA planning commences to organizing teams/resources to finally pressing the submit button for upload through the ESG gateway will be discussed.
At Halloran we are committed towards impacting human health and share the same mission as our clients to allow patients access to safe and effective innovative therapies to treat their unmet needs.