Certara.AI

Overview

Background

Access Publish

Amy Chen

Alondra Sandoval

Gayathri Aiyaswami

This collection provides step-by-step guidance for assembling and publishing eCTD v4.0 submissions via the cloud-based GlobalSubmit Publish application. Topics include managing applications, structuring submission units, organizing documents, validating content, and preparing compliant packages for regulatory delivery in the US and Japan.

Publish (Browser-Based) 

Use the eCTD Tree

Inventory Pane

Preview Pane

View Details

The main user interface features of Publish include eCTD Tree, Inventory Pane (Displays contents of a folder), Preview Pane (Displays contents of a file), and View Details (Displays metadata corresponding to the selected item)

Basic Features of Publish

Create an application

Open an application

Edit application information

Remove an application

Do Not Auto correct PDF Functionality

Create an application, Open an application, Edit application information, Remove an applicaiton

Manage Applications

Add a new submission unit

Add existing repeat sections

Edit submission unit information

Remove a submission unit

Publish a submission unit

Submitting to ESG Gateway

Add, Remove, and Publish a new submission unit as well as Edit submission unit information

Manage a Submission Unit

Create a context group

Modify a context group

Remove a context group

User defined Code and code system

Context groups are folders in a section that are named according to the keywords specified during creation

Manage Context Groups

Adding Folders and Labels

Modifying Folders and Labels

This collection gives all details related to managing Folders and labels in a submission unit.

Manage Folders and Labels

Add a File

Edit the title and file name

Add metadata to a file (Japan 4.0 only)

Download a file

Reuse files

Replace a file

Suspend and unsuspend a relationship

Delete a file

Edit the title and file name, Add metadata to a file (Japan 4.0 only), Download a file, Reuse files, Replace a file, Suspend and unsuspend a relationship, Delete a file

Manage Files

Content Links

Outline Links

This section covers the management of links within the content of the PDF file and management of links in the Outline view of the document from the Preview Pane.

Manage Links in a PDF File

Add a contact

Edit a contact

Update and undo update of a contact

Suspend and unsuspend a contact

Delete a contact

(US eCTD4.0) Managing contacts is done using the Contacts tab, which is accessed by selecting the application or submission in tree and clicking the Edit submission unit button.

Manage Contacts

Get Help

Contact Us!

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