FDA and the Electronic Common Technical Document(eCTD)

In completing Writing Assignment #3 for RGA6207 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:

1. Describe the basics of NDA submission best practices
2. 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
3. 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?)

Sample Solution