Pharma & Biotech Quality Consulting Services

Ocean tide and shoreline, calm and serene approach to pharma quality consulting in Switzerland

  • A tailored, pragmatic approach to building or elevating your Quality System.


    Includes GxP setup for lean teams, customized gap assessments, inspection and license readiness for Swissmedic and other Health Authorities, and remediation programs designed to ensure compliance without unnecessary complexity.

    Is this relevant for you?

    • Are you setting up GMP/GDP activities with a lean team and limited resources?

    • Are you preparing for a Health Authority inspection unsure where to start?

    • Are you planning to apply for a new license and unsure about the scope?

    • Do you have procedures in place, but lack confidence in their inspection readiness?

    • Has your Quality System grown organically and now needs structure and simplification?

    Support is always tailored to your context, team, and stage of development.

  • Support to Qualified Persons (EU, UK), Authorized Persons (Australia) and Responsible Persons / FvP (Switzerland, EU, UK, Australia, Asia).

    Transitional or fractional Responsible Person (fachtechnisch verantwortliche Person - FvP) consulting services in Switzerland - services that ensure continuity, compliance, and confidence.

    The service may include license and inspectionreadiness, decision-making support, and ongoing oversight aligned with Swissmedic and other Health Authorities’ expectations.

    Is this relevant for you?

    • Do you need temporary RP/FvP coverage during a transition, growth phase, or organizational change?

    • Are you preparing for an inspection and need experienced QP/RP oversight?

    • Are responsibilities unclear between global and local quality roles?

    • Do you need confident, independent decision-making support aligned with Health Authority expectations?

    Support is always tailored to your context, team, and stage of development.

  • Support in digitalizing pharma and biotech quality processes and batch release/batch certifications activities.

    Includes guidance on user requirement specifications, GxP digital system selection, computer system validation (CSV) strategy, process and workflowoptimization, and leveraging digital tools to reduce manual workload and enhance compliance.

    Is this relevant for you?

    • Are your quality or batch release processes still heavily manual and time-consuming?

    • Are you implementing or optimizing a digital quality system and need pragmatic guidance?

    • Do you struggle with aligning system validation, workflows, and real operational needs?

    • Do you want to reduce manual workload while maintaining full compliance?

    Support is always tailored to your context, team, and stage of development.

  • Hands-on quality coaching and GxP (GMP/GDP) training involved in real Quality System operations, that empower teams to become self-sufficient.


    Focus on embedding quality mindset, building internal know-how, and guiding new or expanding organizations through compliant operations.

    Is this relevant for you?

    • Do business and operational teams fully understand the role and responsibilities of the RP/QP within your organization?

    • Are you onboarding a new QP/RP and need practical, hands-on training?

    • Do you want to reduce long-term dependency on external consultants?

    • Are you building a quality mindset alongside operational growth?

    Support is always tailored to your context, team, and stage of development.

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