Regulatory Manager (RIR-OC) - R2026x FD02

The video below illustrates the following enhancements:

App What's New
Regulatory Record Management
  • Create Regulatory Authorities

Enable users to create, edit, and manage custom Regulatory Authorities and Submission Types.

Benefits: Ensure flexibility, scalability, and compliance by enabling users to adapt to diverse regulatory landscapes, streamline submission workflows, and maintain control over custom configurations.

 

  • Delete a Submission

Enable users to delete submissions in the 'In Work' state, ensuring better control over draft regulatory submissions.

Benefits: Enhance regulatory efficiency with the ability to delete in-progress submissions, providing controlled management of draft submissions, reducing clutter, and ensuring seamless compliance with regulatory requirements.

 

  • Enhance the User Experience of Regulatory Record Management

    Introduces admin-specific configurations and improved accessibility for submission templates.

Benefits: Enhance user experience and efficiency in regulatory record management with improved UI components, streamlined workflows, and intuitive features like dossier freezing, infinite scrolling, and contextual toolbars.

 

  • Automated Renewal Notification
    Automates reminders for market authorization renewals and re-registrations. 

Benefits: Streamline regulatory compliance with automated notifications for renewal and re-registration requests. This feature ensures timely reminders, reduces the risk of missed deadlines, and enhances efficiency by allowing configurable intervals and acknowledgment tracking.

 

  • Submissions with Specific Model Version Configurations

 Enable users to select and manage specific product configurations or base configurations for one or multiple products during submission creation.

Benefits: Enhance regulatory submission efficiency with the ability to create submissions for specific product configurations across one or multiple products. This feature streamlines the process, ensures precision, and provides flexibility in managing regulatory requirements.

 

  • Submissions with Multiple Products
    Enable users to select and manage multiple physical products, model versions, or product configurations during submission creation.

Benefits: Enhance regulatory submission efficiency with the ability to create submissions for multiple products simultaneously.

For more information, please review the what's new official role page:

https://dshelp-embed.3ds.com/2026x/English/WNRoles/rir-index.html

 

These enhancements are illustrated in the following video:

 

If you have any question or comments on these highlights, please share them with us below. 👇

Thanks!