Case Study: 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 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.