FDA Module 1 Grouped Submissions Q&A
Jun26

FDA Module 1 Grouped Submissions Q&A

The current FDA specifications governing grouped submissions state that Application Type and Submission Type have to agree. Accordingly, you would have no trouble grouping NDA labeling supplements.

Read More
Module 1 Grouped Submissions Explained
Jun19

Module 1 Grouped Submissions Explained

A grouped submission eliminates the need to submit multiple, identical submissions to different applications. For example, a manufacturing part change might impact a dozen applications. In the age of grouped submissions, a new sequence would be created to note the part change, and that sequence would then point to all other applications affected.

Read More

eCTD Cloud Vendor Selection Q&A

GlobalSubmit recently held an educational webinar entitled Regulatory and the Cloud Vendor Selection. Software as a service (SaaS, typically pronounced [sæs]), often referred to as “cloud technology” or “on-demand software,” is a software delivery model in which software and its associated data are hosted centrally, typically in the Internet. The combination of ever-more-abundant bandwidth, increasingly powerful...

Read More

Free Educational Webinar: Regulatory and the Cloud Vendor Selection

Software as a service (SaaS, typically pronounced [sæs]), often referred to as “cloud technology” or “on-demand software,” is a software delivery model in which software and its associated data are hosted centrally, typically in the Internet. The combination of ever-more-abundant bandwidth, increasingly powerful processors, and inexpensive storage is broadening the choices for designing, deploying, and using software....

Read More

Regulatory Publishing Software Q&A

During a recent webinar presentation, GlobalSubmit demonstrated how IND & Pre-IND companies use our software tools to see the same views as the FDA; build their application as the FDA sees it; cut days off the time it takes to quality check bookmarks and hyperlinks; improve communications both internally and with the Agency; improve efficiency and meet important deadlines; reduce risk of technical rejections; and more! We received...

Read More