NDA Medical Writing

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.