[ad_1]
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 eCTDsubmissions• Demonstrate an ability to interpret a publicly available information about different eCTDsoftware solutions• Demonstrate an ability to apply information presented in RGA6207 regarding eCTD submissionsand best practices to a real-world scenarioFor this assignment, you are a Sr Manager of Regulatory Affairs at a small, emerging biotechnologycompany that has completed all aspects of development for a combination drug/device product calledCVT-301. CVT-301 was developed for treatment of the symptoms of Parkinson’s Disease. It is now timefor you to select an appropriate eCTD software tool (or tools) to best assist you in an eCTD-compliantsubmission 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 thissoftware that helps with conversion of word documents to eCTD-compliant PDFs? Is thissoftware that organizes the eCTD documents into their appropriate hierarchy/granularity?)
Sample Solution
What Students Are Saying About Us
.......... Customer ID: 12*** | Rating: ⭐⭐⭐⭐⭐"Honestly, I was afraid to send my paper to you, but splendidwritings.com proved they are a trustworthy service. My essay was done in less than a day, and I received a brilliant piece. I didn’t even believe it was my essay at first 🙂 Great job, thank you!"
.......... Customer ID: 14***| Rating: ⭐⭐⭐⭐⭐
"The company has some nice prices and good content. I ordered a term paper here and got a very good one. I'll keep ordering from this website."
