Preview Synchrogenix RIM Products GlobalSubmit COMMUNICATE and MANAGE

Demo of Synchrogenix Regulatory Information Management (RIM) products GlobalSubmit COMMUNICATE and MANAGE. Build global process around a single solution & Real-time submission management to plan, publish, validate, and report on submission status for every submission type and region!

Read More

Preview Synchrogenix RIM Products GlobalSubmit COMMUNICATE and MANAGE

Demo of Synchrogenix Regulatory Information Management (RIM) products GlobalSubmit COMMUNICATE and MANAGE. Build global process around a single solution & Real-time submission management to plan, publish, validate, and report on submission status for every submission type and region!

Read More

Preview Synchrogenix RIM Products GlobalSubmit COMMUNICATE and MANAGE

Demo of Synchrogenix Regulatory Information Management (RIM) products GlobalSubmit COMMUNICATE and MANAGE. Build global process around a single solution & Real-time submission management to plan, publish, validate, and report on submission status for every submission type and region!

Read More
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