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The emergence of huge pharmaceuticalcompanies with discrete centres of excellence in geographically dispersed locations has upended the classic model of one-stop shopping for all development functions. Having a person in plant for some tech transfers facilitates higher levels of communication.
In addition to delaying optimization of manufacturing and controls, these types of long delays for approvals discourage continuous processimprovements for approved products. Consequently, comparing results across companies and through time will establish an increasingly robust perspective of trends in global approval durations.
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