Trusted Pharmaceutical QA Consultant | GMP & GDP Expert

With over 20 years of experience in pharmaceutical quality assurance, I help companies stay inspection-ready and compliant with global GMP and GDP standards. My expertise spans the full pharmaceutical supply chain, from clinical development to commercial distribution — with a specialized focus on radiopharmaceuticals, PET tracers, and human mass balance (AME) trials.

Having conducted more than 650 supplier audits and 350 internal audits, I support both startups and multinational corporations in meeting regulatory expectations from authorities like EMA, FDA, and local inspectorates. Whether it’s preparing for inspections, qualifying CMOs, or strengthening quality systems, my approach is hands-on, pragmatic, and audit-ready.

As a certified Responsible Person (RP), I support pharmaceutical wholesalers in meeting the requirements of EU Good Distribution Practice (GDP). I conduct internal audits, prepare sites for GDP inspections, and provide guidance on temperature monitoring, risk assessments, product traceability, and documentation systems. I’ve successfully acted as RP on behalf of companies during inspections and have helped businesses implement and maintain fully compliant GDP systems tailored to their operations. I’ve also helped several pharmaceutical wholesale distributors successfully obtain or restore their Wholesale Distribution Authorization — even in cases following serious inspection findings.

I’ve worked extensively with radiolabeled pharmaceuticals for diagnostic and clinical studies, including fluorine-18, zirconium-89, carbon-11, and lutetium-177 compounds. My experience covers the entire GMP lifecycle—from radiolabel synthesis and formulation to sterility assurance and Qualified Person release. I also provide guidance and audits for PET tracer manufacturing, which requires fast, compliant operations due to short isotope half-lives and strict sterile conditions. Additionally, I support radiolabeled human mass balance trials, ensuring all GMP, regulatory, and radioprotection guidelines are met in both the EU and the US.

The core services offered include:

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