When the phone rings for HealthCare Authorities inspection, be it the FDA or the EMA (we are privileged to have done both!), it is you who need our experience and us who need you to be prepared and keep very quiet.
The Inspection Room has space for the representative of the authorities and the language expert, and they will be both working under extreme pressure.
Be prepared, keep calm, stay quiet and collaborate. The more you collaborate, the smoother the inspection will run.
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