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pharma services oehler|3 September 2019

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.

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.

Operational support

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

  • Audits (internal, at suppliers, in the warehouse, etc.)
  • Self-inspections
  • Preparation of/for inspections
  • Product Quality Reviews (PQRs)
  • Management of complaints
  • Training

Outsourcing of the Responsible Person (RP)

 If required, we assume the function as your company’s Responsible Person (RP) -outsourced permanently or for an 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
  • Training

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 establishment licenses (e.g. import and wholesale license including market release).

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

This white paper highlights what it takes to bring a drug to the Swiss market, including the marketing authorisation application MAA), preapproval and launch preparation...
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