Managed Service Solution for Annual Product Review (APR)
Download a . PDF of this Case Study here:Managed Service Solutions for Annual Product Review (APR) Client Business Situation Client was experiencing multiple problems with its Annual Product Review (APR) process for its externally manufactured products, which included OTC Pharmaceuticals, Cosmetics, and Medical Devices (See Note). Client was also exceeding its budget for the execution […]
Clinical Study Program & Site Compliance
Client Business Situation Client was a large physician practice group with a substantial clinical study practice. Due to the nature of the studies conducted and association with significant pharmaceutical company clinical trials, FDA conducted an inspection of the practice location and conduct of individual clinical studies. This was the first experience the practice had with […]
