Regulatory Submissions Management

Description

The Regulatory Submissions Management form allows users to create, track, and manage records essential for preparing, reviewing, and submitting regulatory documentation. It provides a structured workflow to define, review, and approve submissions, ensuring all regulatory filings are properly documented and controlled. Users can initiate new submissions, update documents, track approval status, and maintain records of past submissions for regulatory and operational traceability. This ensures a consistent and systematic approach to compliance, supporting adherence to regulatory requirements and facilitating efficient interactions with regulatory authorities.

Access the Regulatory Submissions Management

• Step #1: Move your cursor to the "MODULE" tab located in the top-left corner of the screen.

• Step #2: In the drop-down menu that appears, hover over "Regulatory Compliance Management". This will expand a new menu displaying the following modules:

  • Quality Review

  • Regulatory Submissions

• Step #3: Pass your cursor over "Regulatory Submissions". Another drop-down menu will appear, showing the forms available within this module.

• Step #4: Select the "Regulatory Submissions Management" option from the drop-down menu to access the main dashboard for this module.

Guide to Access Regulatory Submissions Management

Notes: Only active users with a license, access rights, and privileges for this form can access the information. If you do not have access to a specific form or its functionalities, contact your company’s system owner or administrator to request the necessary access and privileges.