Regulatory Inspection Assistance

PSC can assist you before, during, and after inspections from regulatory authorities. Our multi-disciplined staff have experience across all major industry sectors including Pharmaceuticals, Biologics, and Medical Devices. We have substantial expertise in assisting clients in meeting the requirements of the FDA, EU, ICH, PIC/s and various pharmacopeia. Our worldwide staff can also advise you on local regulatory requirements specific to each country.

Prior to your real inspection we can prepare you by performing mock inspections. During your inspection we can be present on site to provide technical input and organizational assistance. After your inspection we can help with the remediation process to address inspection observations as well as assist with the written response to inspectors.

If you would like more information, get in contact with us directly here.