What the DMF!: Spotlight on Forge's Drug Master File

Gene therapy developers' IND application process is an onerous and critical undertaking in their journey of delivering safe and effective therapies to patients. A key benefit of partnering with a CDMO like Forge, which offers a full suite of regulatory services, is that we maintain a DMF with the FDA. This provides a set of CMC platform documentation that can augment an entire section of a program’s IND application and can save months of time.

Chris Shilling, M.S., SVP of Regulatory Affairs, and Angela Coy, Ph.D., Senior Manager of Regulatory Affairs, delve into how Forge’s DMF serves as a regulatory CMC platform with the ability to adapt to our clients' needs for bespoke outcomes.