How to prepare a study data standardization plan (SDSP) for FDA
Get up-to-speed on Study Data Standardization Plan (SDSP) for FDA submissions. Read the blog post…
Certara2016 年 7 月 25 日
Submitting eCTD in advance of a milestone application
While advanced GPS systems and the advent of Big Data analytics are negating some of…
Certara2016 年 5 月 10 日
Best practices for placing drug master file reference letters in regulatory applications
Within drug applications (ANDA, BLA, IND, or NDA), eCTD (electronic common technical document) Module 3…
Certara2016 年 3 月 14 日
FDA DataFit: An introduction
Explore FDA DataFit, a project ensuring high-quality, compliant data to streamline drug reviews, reduce delays,…
Certara2014 年 8 月 19 日
FDA JumpStart: An introduction
Discover FDA JumpStart, a ground-breaking service accelerating drug reviews by enhancing data quality, identifying risks,…
Certara2014 年 7 月 16 日
Hyperlinking: Making the most of navigation in eCTD submissions
When authors generate documents intended for electronic submission they use blue-colored font to indicate where…
Certara2014 年 2 月 5 日
