Preparing for a successful commercial launch starts long before FDA approval.
Join AMRI, PCI Pharma Services, and Cardinal Health Regulatory Sciences for this three-part webinar series as we review this complex process and identify common challenges to commercialization. We will focus on what drug synthesis, clinical logistics, packaging design, and regulatory considerations should be thoroughly planned and checked for a successful commercial drug launch.
Regulatory Considerations for Clinical to Commercial Launch
A review of the Investigational New Drug (IND) application and the FDA’s marketing authorization process, including common areas that are underestimated
Expedited FDA programs (i.e. Fast Track, Breakthrough, Accelerated Approval, etc.)