Quality Assurance

With a good quality management system, you ensure that your products and processes comply with the required level of quality and “good practice” standards – from development to patient use. We offer support as required.


Frequently required services

  • Operational support

    Operational support

    We advise and support you in the areas of Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP):

    • Audits (internal, at supplier's, in the warehouse, etc.)
    • Self-inspections
    • Preparation of/for inspections
    • Product Quality Reviews (PQRs)
    • Management of complaints
    • Trainings
  • Outsourcing of the Responsible Person (RP)

    Outsourcing of the Responsible Person (RP)

    If required, we assume the function as your company’s Responsible Person (RP) -outsourced permanently or for a interim period during maternity leave or in the case of staffing shortages:

    • Assuming responsibility and overseeing the quality of your products
    • Marketing approvals
    • Deviation management
    • SOP management
    • Trainings
  • Strategic consultation

    Strategic consultation

    Benefit from our expertise and experience in these areas:

    •     Obtaining an Establishment license in Switzerland
    •     Evaluation of the required types of permits for your company

     

    If required, we offer the use of our establishment licenses to companies without an establishment of their own in Switzerland until they have obtained their own establishment licenses (e.g. import and wholesale license including market release).

  • Implementation and maintenance of quality management systems

    Implementation and maintenance of quality management systems

    We are happy to advise you in the following areas:

    •     Evaluation and optimisation of existing quality management systems
    •     Implementation of new quality management systems

Your contact

Any questions?
I would be delighted to answer them.

Elizabeth Heitzer
Head of Quality Services
+41 44 787 70 20
e.heitzer@pharma-services.ch


 

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QMS checklist for annual Quality Assurance tasks:
Planning to enter the Swiss market? We provide our establishment license if required:
We have been committed to serving our clients enthusiastically and cooperatively since 1997: