About this Project
OBJECTIVE
Preparation for FDA prior-approval.
SERVICES
PSC® performed mock FDA prior approval audit. Performed inspection of cGMP Manufacturing facility and the associated cGMP Quality Systems. PSC® developed audit response plans, corrective action and regulatory compliance plan, and trained staff. PSC®, developed cGMP training content for facilities.
PROJECT SUCCESS
The mock audit led to a successful FDA prior approval audit. The company is also still a client of ours to this day.
