Achieving regulatory excellence in Life Sciences companies depends on a combination of process optimisation, 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.
Fostering Effective Life Science Affiliate Collaboration For Global Regulatory Process Optimisation
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.
Fostering Effective Life Science Affiliate Collaboration For Global Regulatory Process Optimisation
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.
Fostering Effective Life Science Affiliate Collaboration For Global Regulatory Process Optimisation
Feedback from affiliates worldwide
Our new research includes detailed feedback from 320 local offices / affiliates representing 94 countries. The affiliates represented 20 sponsor companies, most of which provided between 10 to 25 contributing affiliates of varying size and geographic location to participate in the research.
Fostering Effective Life Science Affiliate Collaboration For Global Regulatory Process Optimisation
We started some limited affiliate research in 2013 and have been charting various aspects of affiliate operations in managing regulatory information as part of our World-Class RIM study program for around a decade. This has enabled us to compare the current findings with a baseline, and we have determined that companies are now roughly halfway to achieving a strong level of operating performance from a local affiliate perspective.
Fostering Effective Life Science Affiliate Collaboration For Global Regulatory Process Optimisation
As things stand, 52% of the time spent by affiliates on managing their Regulatory processes continues to involve use of local and regional tools, in addition to or instead of global, authoritative systems. The remaining 48% of time is now used in centrally designated platforms which is…
Fostering Effective Life Science Affiliate Collaboration For Global Regulatory Process Optimisation
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