Datasheet | September 8, 2022

NDA/MAA Preparation Survival Guide: Managing Operational Complexities

Achieving Clinical Operations

While all marketing applications are unique, there is no doubt they share common threads. Understanding each individual project’s complexities in advance can help teams create effective approaches for planning, mid-stream adaptation, and final submission.

  • Establish baseline fundamentals
    • Start by building an organized, effective team and optimized communication plans so the rest of the process can proceed smoothly
  • Create the submission timeline
    • Other than the actual submission files, the timeline is the most crucial document for any submission. It serves as a roadmap and organizational tool for every aspect of the process.
  • Be flexible when the timeline shifts
    • It's not a matter of whether a timeline will change, but how to adapt when it does. Be prepared to respond intelligently and prioritizing ways to maximize efficiency.
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