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

Prior to your 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 the inspectors.

If you have a need for our Regulatory Inspection Assistance services, please Contact Us.