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Your NDA Preparation Should Have Started by Now: Checklist for Planning and Managing Your NDA Submission

Throughout our years of preparing and filing Food and Drug Administration (FDA) submissions, Premier Consulting has often encountered sponsors who cannot file a New Drug Application (NDA) or Biologic License Application (BLA) within expected timeframes, most commonly due to a failure to start and complete prerequisite activities before the targeted filing date. In this checklist, we will highlight those requirements that seem to be the most misunderstood, including CMC considerations, document management, pre-filing requirements, and more.

Download the Checklist