Throughout my career, I have conducted both internal and external inspections in facilities in Europe and abroad. My experience includes inspecting Drug Substance and Drug Product manufacturers, ensuring compliance with rigorous industry standards. I participated in FDA inspections and supported an EMA cell therapy Drug Product inspection in the US, contributing to the evaluation and approval process of innovative therapies.
Additionally, I have performed individual inspections for manufacturers of virus production, cell therapy, and generic medicinal products, ensuring their adherence to regulatory guidelines and quality standards. Internally, I have executed thorough inspections to maintain a high standard of operational excellence.
Inspections Service
I now offer my expertise as a consultant, providing guidance and support to organizations seeking to maintain the highest standards of quality and compliance. My services include tailored inspection strategies and compliance judgments to ensure your operations—as well as those of your subcontracted companies—meet industry expectations.