Rolling NDA and BLA Submissions: Accelerate Your Timeline for Review
Accelerate your FDA review process with a rolling NDA/BLA eCTD submission with Certara’s GlobalSubmit eCTD software and eCTD publishing specialists
Accelerate your FDA review process with a rolling NDA/BLA eCTD submission with Certara’s GlobalSubmit eCTD software and eCTD publishing specialists
Within drug applications (ANDA, BLA, IND, or NDA), eCTD (electronic common technical document) Module 3 pertains to quality data. It has become increasingly common for sponsors to reference a Drug Master File (DMF) within this module. A DMF contains detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of drugs … Continued