Certara.AI

Amy Chen

Alondra Sandoval

Gayathri Aiyaswami

The GlobalSubmit Collection is a compilation of informative articles and guides designed to assist users in comprehending and effectively utilizing the platform's features.  Please note that articles with a leading asterisk * includes a video tutorial followed by the step by step instructions. 

Certara.AI GlobalSubmit

GlobalSubmit Release Notes

Known Issues

Introducing Certara Admin, bringing major changes to user and security management across the Certara data sciences platform.

Introducing Certara Admin (CAD) in GlobalSubmit

Glossary

References

GlobalSubmit uses Okta to enforce secure password policies.

GlobalSubmit's Okta Password Policy

Bookmarking GlobalSubmit in Okta

How to switch between English and Portuguese

Setting a Default Languages

Includes some basic overview and related topics about GlobalSubmit.

General Information

This page walks you through the controls in the navigation bar at the top of the application.

Navigation Bar

Upload Files

Upload Folder

Create a Folder

Rename a File

Download Files and Folders

Delete Files and Folders

Load an Application/Sequence

Remove an Application/Sequence

Activity Page

Configuration

Generate Application and Submission Reports

This collection provides detailed guidance on using GlobalSubmit Load to manage files, folders, and application sequences during the review process. Topics include navigation, upload/download actions, folder operations, and configuration settings.

Load

Overview

Loading an Application

Delete an Application

Update an Application

Grouped Submissions

View Status

View High Errors Log

View All Errors

Run Diagnostics

This collection provides guidance on using GlobalSubmit Validate to analyze eCTD and NeeS submissions for technical accuracy, manage application data, and prepare content for regulatory review. Topics include error detection, report generation, diagnostics, configuration, and navigation of key interface components.

Validate

Generate Reports

Aggregate Reports

This is a compilation to give an overview and detail explanation on the Reports option in Validate.

Reports

Access Review

Open an Application

This collection covers the browser-based eCTD viewer used for cloud-hosted regulatory review. Articles include guidance on accessing applications, navigating the eCTD tree, using the inventory and preview panes, viewing submission details, and managing PDF links—all designed to support efficient, global review workflows.

Review (Browser-Based) 

Use the eCTD Tree

Inventory Pane

Preview Pane

View Details

Convert for Publish

The main user interface features of Review 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 Review

Background

Access Publish

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) 

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

Pre-Installation Information

Install Desktop

This collection provides instructions for installing and configuring GlobalSubmit Desktop, which includes tools for both publishing and review. Topics cover pre-installation requirements, accessing Validate, downloading the Desktop client, setting up Acrobat, and ensuring proper permissions for installation.

GlobalSubmit Desktop Installation

Background to Review (Desktop-Based)

Open Applications

Open File in Native Application

Share Files (Link2Share)

Save Grids to Excel

Favorites

Search

Print

Download Files

Run Reports

Appendix A: Shortcut Keys Available in Review

This collection provides guidance on using the desktop-based GlobalSubmit Review application to evaluate eCTD and NeeS submissions. Topics include application access, document lifecycle review, annotations, reporting, file sharing, and navigation features—designed to mirror the regulatory agency’s view and streamline the submission review process.

Review (Desktop-Based) 

Basic Features of Review Introduction

Navigation Pane

Details Pane

Views Pane

The interface is broken into to four panes: Navigation Pane, Details Pane, Views Pane, and Preview Pane

Customize Review Introduction

Re-Size Panes

Auto Hide

Re-Position and Undock Preview Pane

Modify Preferences

Displayed Columns

Customize panes, review preferences, and columns

Customize Review

Reviewed Checkbox Information

Columns Available on Details and Inventory Tabs

Once files have been fully QC’d, the Reviewed column can be checked off.

Reviewed Checkbox

Filter Modules or Sequences

Filter by Content

Filter by Sequence

Filter by Regulatory Activity

By default, Review displays all modules and all sequences.

Annotations Introduction

Create Annotations

Search for Annotations

The Annotations tab allows you to enter comments about the submission.

Annotations

CrossCheck Introduction

Preview Pane in CrossCheck

The CrossCheck tab displays all bookmarks and links that are contained within files in the selected node and its subsections, from the Navigation pane. Each bookmark or link is displayed as a row.

CrossCheck

This collection provides comprehensive guidance on assembling and publishing eCTD v3.3 and earlier submissions using the desktop-based GlobalSubmit Publish application. Topics include managing applications and sequences, structuring content, linking and bookmarking, validating submissions, and preparing compliant packages for delivery to regulatory authorities across multiple regions.

Publish (Desktop-Based) 

This section provides some general background and key concepts for using Publish.

How to Use Publish Views and Live Validation in GlobalSubmit eCTD Suite for Efficient eCTD Submission Management

Publish and the GlobalSubmit Quality Suite

Understanding eCTD Applications, Sequences, and Regulatory Activities: A Guide to Efficient eCTD Submission Management

Applications – Sequences – Regulatory Activities

Understanding eCTD File Management: Files vs File References in Regulatory Submissions

Files and File References

Understanding eCTD File Management: Source Files vs Published Files in Regulatory Submissions

Architecture and File Transfer

Understanding eCTD States: Managing File and Section Status for Regulatory Submissions

States

Mastering Publish Functionality: Menus, Tabs, and Shortcut Keys for Efficient eCTD Submission Management

Usage Notes

Understanding eCTD Publishing Permissions and Workflow: Reserving Sections, Applying States, and Saving Changes

Summary of Key Points

Customizing Publish: Settings and Features for Efficient eCTD Compilation and Regulatory Compliance

Customize Publish

A Comprehensive Step-by-Step Guide to Creating a New Application

Create a New Application

Converting Existing Applications for Use in Publish: A Guide to Getting Started

Import an Existing Application

Managing Existing Applications in Publish: How to Open, Edit, and Update Properties

Modify Application Properties

How to remove an application from GlobalSubmit Publish Desktop

Remove an Application

How to manage applications within GlobalSubmit Desktop

How to add a new sequence in GlobalSubmit Publish Desktop

Add a New Sequence

Streamlining Sequence Creation: How to Use Repeat Sections in Publish

Add Existing Repeat Sections

Opening and Modifying Existing Applications in Publish: A Step-by-Step Guide

Add a Grouped Submission

How to Edit Sequence Properties in Publish

Modify Sequence Properties

Editing Sequence Content in Publish: Understanding the Differences Between Origin, Life Cycle, and Current Views

Edit a Sequence

How to Place a Reservation on an In Progress Sequence or Section in Publish

Reverse for Edit

Conflict Resolution in Publish: Managing Multiple Users and Reservations

Manage Reservations

How to manage a sequence within GlobalSubmit Desktop