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NDA Medical Writing

The Challenge 

A Midwest-based pharmaceutical client needed medical writing and biometric support for a 505(b)(2) New Drug Application (NDA). The client had little NDA filing experience and needed a experienced resources to help develop a filing strategy, complete programming and statistical analysis, and author CTD and other documents.

  • Strategic differences in utilizing literature for supporting information
  • Competitor scheduled to file similar product in the same indication in the same time-frame
  • Statistical sub-analyses in flux
  • Timelines tied to corporate goals

The Results 

  • Planet Pharma helped the client complete the first part of the submission 1.5 weeks ahead of schedule.
  • The second part of the submission was completed on time and accepted for review by the agency without issues.

The Solution 

  • Planet Pharma found and placed experts to help the client create a submission strategy approved by FDA that allowed for a two-part submission approach.
  • We also deployed 10+ resources to write and quality review Modules 2 and 5. In addition, literature strategy to support two key areas of the submission was developed and included a separate team of scientists and medical  reviewers who reviewed over 1000+ literature publications that were  summarized in the submission.
  • These resources also aided the client’s biometrics team with programming and statistical input, creating ad-hoc tables and analyses as requested by the client’s senior management. The client also requested label development and
    narrative writing support as the project progressed.