Services
I support pharmaceutical companies through clearly defined assignments – from external Responsible Person (RP) services and interim quality leadership to GMP/GDP compliance and inspection readiness.
Client Situation
Your company requires an external Responsible Person (RP), either on an ongoing basis or for a specific project.
My Support
I assume regulatory responsibilities within the agreed scope and applicable legal framework, providing independent, personal support backed by extensive experience as a Responsible Person.
Your Benefit
Access to an experienced Responsible Person without a lengthy recruitment process.
Client Situation
Your internal Responsible Person is temporarily unavailable, or additional coverage is advisable from a regulatory perspective.
My Support
I provide deputy coverage, undertake approvals and assessments within the agreed scope, and ensure continuity.
Your Benefit
Continuity of regulatory responsibility during absences or transitional periods.
Client Situation
You require quality leadership at short notice, whether to cover a vacancy, support a transformation project or prepare for an inspection.
My Support
I temporarily assume leadership responsibilities within the quality function, prioritise key issues and support the team.
Your Benefit
Stability, clear priorities and reduced pressure on the team during challenging periods.
Client Situation
Regulatory requirements need to be implemented, reviewed or updated following operational changes.
My Support
I assess processes against applicable GMP and GDP requirements, identify gaps and initiate appropriate measures, ensuring that actions are documented and practical to implement.
Your Benefit
A structured overview of the current implementation status and prioritised next steps.
Client Situation
A customer audit or regulatory inspection is approaching, or findings from a previous audit remain unresolved.
My Support
I conduct gap assessments, prepare documentation and relevant personnel, and support follow-up activities.
Your Benefit
Thorough preparation, with identified weaknesses and well-organised documentation. No specific audit or inspection outcome is guaranteed.
Client Situation
Your employees require practical training in GMP/GDP, Responsible Person (RP) responsibilities, and the management of deviations and CAPA.
My Support
I deliver on-site training tailored to your operational processes and specific questions.
Your Benefit
A shared understanding of regulatory requirements and greater confidence in applying them in day-to-day operations.
Client Situation
Collaboration with suppliers and external partners requires clearly defined quality responsibilities and transparent partner assessments.
My Support
I support the preparation and negotiation of Quality Agreements, as well as supplier qualification, supplier audits and due diligence assessments.
Your Benefit
Clearly defined responsibilities, well-founded supplier assessments and a reliable basis for collaboration with external partners.
Client Situation
A specific quality or compliance issue requires additional technical expertise or needs to be addressed within a defined timeframe.
My Support
I support you in systematically assessing the issue, defining appropriate measures and implementing practical solutions.
Your Benefit
Clear recommendations and targeted support in addressing your quality projects.
Client Situation
As a start-up or biotechnology company, you are establishing quality structures from the ground up or preparing for your first audits.
My Support
I help you establish a lean, scalable quality management system and address regulatory expectations at an early stage.
Your Benefit
A solid foundation that can grow with your company.
During an initial consultation, I will discuss your current situation, the scope of your requirements and potential next steps – without obligation and in confidence.