Expertise
An overview of the areas in which I support pharmaceutical companies. The information provided is intended as a description of my expertise and does not constitute legal or regulatory advice for individual cases.
Since 2010, I have served as a Responsible Person (RP) under Swiss pharmaceutical regulations. My experience covers the manufacture of active pharmaceutical ingredients (APIs) and finished medicinal products, as well as the import, export and wholesale distribution of medicinal products. I also have experience in the handling of controlled substances.
I have experience in establishing, reviewing and further developing pharmaceutical quality systems, with a focus on clear interfaces, defined responsibilities and practical, fit-for-purpose documentation.
I am familiar with GMP requirements across different manufacturing environments and support their implementation through practical, clearly defined and traceable processes.
I have extensive experience in the storage, transportation and supply chain management of pharmaceutical products. My particular focus is on ensuring product integrity and traceability throughout the distribution chain. As Chair of the APIC Task Force on Good Distribution Practice, I made a significant contribution to the revision of the guidance document "GDP for APIs: How to do".
I have experience with regulatory requirements and inspection environments relating to active pharmaceutical ingredients and finished medicinal products, including the interfaces between manufacturing and distribution.
I am familiar with pharmaceutical quality and regulatory requirements relating to the import, storage and further distribution of medicinal products in Switzerland and within the European regulatory environment.
I apply risk assessments where they support decision-making, using appropriate methodologies, well-founded assumptions and documented justifications.
I assess deviations, lead root cause analyses and develop corrective and preventive actions (CAPAs). I also support change management processes to ensure that risks are assessed in advance and monitored throughout the product lifecycle.
I have experience in supplier qualification and oversight, from initial assessment through to the ongoing evaluation of critical suppliers.
I prepare teams for audits and regulatory inspections, review documentation and support follow-up activities, with the aim of ensuring a realistic assessment of the organisation's current state of compliance.
During an initial consultation, I will discuss with you whether and how my expertise could support your organisation.