Remove Documentation Remove Pharmaceutical Companies Remove Process Improvement Related Topics
article thumbnail

Process improvements and in-person monitoring help U.S. pharmaceutical company achieve on time for Phase III clinical trials

Impact Pharmaceutical Services

pharmaceutical company to oversee a 6 month, DS manufacturing as Person-In- Plant (PIP) and assist with preparation of associated submission documents related to Phase III clinical trial batches. Download The Case Study The post Process improvements and in-person monitoring help U.S.

article thumbnail

An Evaluation of Postapproval CMC Change Timelines

ISPE

In addition to delaying optimization of manufacturing and controls, these types of long delays for approvals discourage continuous process improvements for approved products. Consequently, comparing results across companies and through time will establish an increasingly robust perspective of trends in global approval durations.