REGULATORY TEMPLATES, STANDARDS & NAMING CONVENTIONS

Client Challenge

Several pharmaceutical companies (from small to large) have had a need to streamline their regulatory operations by developing and implementing submission (and other supporting) templates, standards, and naming conventions. These improvements would ultimately optimize regulatory submission processes.

Red Nucleus Solution

For one client in particular, the Red Nucleus team worked with R&D functions to develop a suite of 350+ submission templates. The templates followed the electronic common technical document format and provided the required information per the International Council for Harmonisation guidelines. The templates were loaded within the document management system and were made accessible to all R&D functions with responsibility for authoring submission documents. The Red Nucleus team developed a file guide that provided standard naming conventions and placement rules for all document types across R&D. The file guide provided standards for all regulated and nonregulated documents.

Value

This project resulted in streamlined operations and enhanced quality of submissions globally, reduced work required to “start” a submission, streamlined “submission-ready” documents, and enhanced “search and retrieve” functionality.

R&D leaders were impressed by the magnitude of impact these deliverables had on overall R&D operation efficiency.