EU and FDA Inspection Readiness
We have extensive experience of preparing companies throughout the world for MHRA or other EU regulatory inspections and our success rate is enviable.
Perhaps more surprising is our excellent record of preparing European clients for FDA inspections. We offer many advantages over US-based consultancies in this respect:
- We are totally familiar with FDA regulations and expectations during inspections because of our extensive work with US-based clients
- We have practical experience of how the FDA carries out overseas inspections, whereas many US consultancies have experience only of domestic investigations, which are very different both in duration and focus
- We have strong cultural links to Europe, but we also share a common language with the USA and we understand the US mentality which allows us to bridge the gap between European and US philosophies
- We are based in Europe, so the cost of using our services is lower than using US-based consultancies, and we are more accessible for support in the final preparation phases
