Inspection Facilitation Without Local MAH Presence

Regulatory inspections can pose significant risk for marketing authorisation holders operating without a local presence. In Belgium and the Czech Republic, the absence of in‑country infrastructure added complexity around inspection logistics, authority expectations, and real‑time access to documentation.

This case study conducted by Prime Vigilance, a sister company of Ergormed Clinical Research, highlights how trusted local representation and centralized oversight enabled inspections to proceed smoothly and in full compliance. Experienced local PV professionals acted as the primary interface with national authorities, coordinating inspection hosting, documentation flow, and follow‑up activities under a unified governance framework. Clear communication and harmonised responses ensured consistency across countries while reducing operational burden on the client. The outcome demonstrates how proactive inspection facilitation can mitigate compliance risk, support positive authority interactions, and deliver reliable outcomes—even when no local MAH presence exists.

Access the full case study to explore practical approaches to inspection readiness in complex operating models.