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Regulatory

  • Prepare submission for the Swiss authorities

  • Ensure the maintenance of the approval

  • Ensure the interface between the industry and the Swiss authorities

  • Give advice in the interpretation of the rules

  • Update the required documentation in accordance with the current regulation

Quality

  • Prepare inspection submitted by Swiss authorities

  • Assess the GMP-compliance with the Swiss requirements

  • Review the documentation and SOPs

  • Ensuring a CAPA system

Translation

  • Translation of scientific medical documents into the 3 Swiss national languages

  • Translation of pharma documents to be submitted to the Swiss authorities

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