MANAGE

A Central System to Track Submission Data and Regulatory Activity Status

GlobalSubmit’s MANAGE gives regulatory operations teams the high-level data needed to manage present and future workloads so that resources can be allocated to the highest priority submissions. When a submission is filed, the system will transition to monitoring the status of each regulatory activity or decision you are waiting on from a regional health authority.

RIMS software submission tracking

MANAGE provides scalability as your organization develops new products and moves further along the lifecycle of active products.

In a typical scenario, a company has a number of active INDs, but no active marketing applications. As the company matures, 4 of those active INDs become marketing applications to 4 separate countries. Planning, managing and reporting on submission and regulatory activities become virtually impossible if the correct system is not in place.

Layers of complexity can add up quickly in regulatory affairs. The design of MANAGE maintains its simplicity as your organization scales. Employees can tailor views to their job roles and easily locate data.

Submission Tracking

Spreadsheets do not suffice for managing everything that goes into a regulatory submission. GlobalSubmit’s MANAGE tool is a scalable system for tracking submission workload data. That data can then be used to allocate resources to high-priority submissions.

Views can be customized to give each individual within a regulatory department only information relevant to their job role.

Regulatory Activity Status

GlobalSubmit MANAGE provides real-time awareness as to the regulatory status of each product in your global portfolio. What was approved and when?

With just a few mouse clicks a user is able to edit and run reports on your organization’s historical and upcoming global regulatory activities filtered by region, product, time increment, etc.

Solution Benefits

  • Capture vital submission planning information and associated metadata
  • Allocate resources to priority submissions based on workload data
  • Anytime, anywhere access with Secure CLOUD
  • Keep track of regulatory activity status for all active products worldwide (Approved, Pending, Clinical Hold, etc.)
  • Integration with GlobalSubmit VALIDATE and REPORTS

Challenges Addressed

  • Stop gap use of spreadsheets to track submission deliverables and due dates for multiple products
  • Frustration with inefficient systems where data entry and sharing are difficult
  • Scalability, customization and access for each user
  • Lack of real-time reporting based on submission activity and projections