Prerequisite: Create an eCTD Compliance Package
To review and submit an eCTD compliance package:
Navigate to Regulatory Library > eCTD Submission Ready Documents.
Select the compliance package.
Open the relevant submission form, such as the 2253.
Some of the information will auto-populate. Download the form, open it in a PDF editor, fill in the rest of the form, and sign it.
From the All Actions menu, select upload a new version to upversion the document with the filled-in, signed form.
Select the updated file, and click Upload.
Return to the binder.
Review the rest of the documents in the binder to ensure accuracy.
From the Workflow Actions menu, select Send for Review if the compliance package needs to be reviewed. Otherwise, select Change State to Submission Ready.
Click Start to begin the workflow.
Next, from the All Actions menu, select Export Compliance Package.
Click complete on the task.
Select Revise and Resubmit if revisions are required, otherwise select Submitted, and click Complete.
