basics of NDA submission best practices

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In completing Writing Assignment students will have the opportunity to:

  • Demonstrate an understanding of the importance of choosing eCTD software to assist in eCTD submissions
  • Demonstrate an ability to interpret a publicly available information about different eCTD software solutions
  • Demonstrate an ability to apply information presented in RGA6207 regarding eCTD submissions and best practices to a real-world scenario

For this assignment, you are a Sr Manager of Regulatory Affairs at a small, emerging biotechnology company that has completed all aspects of development for a combination drug/device product called CVT-301.CVT-301 was developed for treatment of the symptoms of Parkinson’s Disease.It is now time for you to select an appropriate eCTD software tool (or tools) to best assist you in an eCTD-compliant submission of your company’s first NDA.

As the Sr Manager of Regulatory Affairs, it is your task to:

  • Describe the basics of NDA submission best practices
  • Describe the reasons for why eCTD software is needed to help in the submissions process, including details of HOW the software program (or programs) can help
  • List 3 to 5 eCTD software products on the market and briefly describe their capabilities (Is this software that helps with conversion of word documents to eCTD-compliant PDFs? Is this software that organizes the eCTD documents into their appropriate hierarchy/granularity?) A simple google search can help you to easily locate some different software products that are marketed to help regulatory professionals compile eCTD-compliant IND and NDA submissions.This Written Assignment should be comprised of 3-5 pages of content (including references)