STEVE GENS
Managing partner of Gens & Associates

Abstract

For too long, Life Sciences local company affiliates have felt underrepresented in the pursuit of streamlined regulatory information management on a global scale. Now that new research has confirmed this, it’s up to central organizations to determine how to purposefully increase affiliate participation in efforts to improve global regulatory information management (RIM) design so there are no gaps in the data or inefficient processes. Steve Gens of Gens & Associates discusses the findings of a new, far-reaching global regulatory study into the challenges facing affiliates – and what matters to them in the pursuit of solutions.

Achieving Regulatory excellence in Life Sciences companies depends on a combination of process optimization, effective global systems, high data quality, and better Affiliate collaboration. One weak link in that chain could risk compromising all of the other efforts and investment.

Yet highly manual processes, specific local market requirements, and tool usage inconsistencies have often meant a gap in global information visibility and flow which adds risk to key regulatory processes.

This is the subject of important new research we have just published at Gens & Associates. It is the most comprehensive available to date looking at the evolving role and importance of local affiliates in efforts to make global regulatory processes more consistent and effective through optimized systems and tools.

These processes include submission forecasting and planning; product registration management; health authority interactions and commitment management; local label management; submission content management, and archiving; regulatory intelligence management; and promotional material management.