EFFECTIVE REGULATORY SUBMISSIONS

Client Challenge

The client wanted to optimize its submission management approach for major and daily submissions.

The submission process included cross-functional stakeholders. Some roles and responsibilities were unclear (eg, who chairs the submission team, Global Regulatory Affairs, or program management?). Other challenges encountered included inaccurate or incomplete submission components, and departments not submitting information on time, in the right system, or in the correct format.

Red Nucleus Solution

Red Nucleus led a cross-functional team to establish the submission process for major and daily submissions. The team obtained buy-in and alignment of the future process, which was essential for a successful implementation.

Value

The company successfully implemented the submission management process, which drove timelines, roles, responsibilities, standards, and placement rules to ensure efficient and effective submissions.