Preparation for EU and FDA Inspection

Let us help you prepare for your EU or FDA regulatory inspections by:

• Performing mock-regulatory inspections and highlighting weak areas in advance of your regulatory inspection. 

• Working with you to address non-compliances in advance of the regulatory inspector’s visit.

• Training your staff on how to handle a regulatory inspection.

 Mock-regulatory inspections are a great way to achieve this in a safe environment for your staff

  Self Inspection

• Self Inspection is a very powerful tool by which you can identify the vulnerable areas of your business operations
  

• We can provide a fresh pair of eyes. As trained auditors, we can participate in your audit teams to provide an independent and objective input which is often the key to picking up problems that need to be addressed

 Audit Remediation

• Following an EU or FDA inspection, we can help you to pick up the pieces and address those non-compliances that were found

• But why wait until then? We can work with you to remediate findings from your own internal audits or management review processes, from audits by your customers or your Corporate bodies

  Third Party/Third Country Audit Service

• Snowed under trying to operate with multiple supply partners and manage the increasing risk of counterfeiting of raw materials and finished product? We can help!

• As experienced, well trained and well travelled auditors we can combine this perspective with comprehensive and detailed evaluations of your third parties within both the developed and developing worlds