When the phone rings for a Health Authority inspection—whether from the FDA or the EMA (we’ve successfully supported both!)—that’s the moment when our experience becomes your strongest asset. And it’s the moment when we need you to be prepared, focused, and discreet.
The Inspection Room is a high‑pressure environment. Only two people belong there:
- the Health Authority representative, and
- the language expert supporting the process.
Both operate under intense scrutiny and tight timelines.
Your role is simple but crucial: Be prepared. Stay calm. Remain silent. Collaborate fully.
The more aligned and cooperative you are, the smoother the inspection will unfold.
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