QSCS was hired to assist in remediating post market surveillance issues for a pharmaceutical manufacturer. Approximately 1,000 historical records were reviewed, updated, and properly documented. QSCS worked alongside the company providing recommendations and support with any and all correspondence with the FDA.
While on site, one of the QSCS consultants identified a less than efficient, potentially unsafe, process by which the company was handling hazardous waste.
A solution was identified and a more efficient, safer, process was put in place which delivered $645K in annual savings.