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With our expertise, you will be leaving nothing to chance
Are you planning to start distributing medicinal products in Switzerland with your company? Would you like to update your existing quality management system? Do you need support for upcoming inspections by the authorities or for processing audit findings? Do you have staff shortages in your quality assurance team? We can help you in all these cases. We can offer you strategic advice and practical support in setting up and maintaining your pharmaceutical company's quality management system. If you wish, a specialist from our team can take over the position of the responsible person (RP) in your company.
Every pharmaceutical company is inspected before being granted an establishment license, and at regular intervals thereafter. Swissmedic, in collaboration with the Cantonal inspectorates, is responsible for the inspection system in Switzerland and issues or amends establishment licences for pharmaceutical companies.
We are happy to support you in this regard:
Advice on the required authorization modules
Preparation of the application for an establishment license
Preparation for inspections and follow-up
Participation in an inspection
Pharmaceutical companies are obliged to audit their direct contractors before starting operations and at regular intervals thereafter. It must be ensured that the company complies with the applicable rules of good distribution practice (GDP) or good manufacturing practice (GMP).
We will carry out a GDP/GMP audit of your contractor on behalf of your company or support your audit department as an observer/co-auditor.
A pharmaceutical company should review all aspects of good distribution practice at regular intervals as part of a self-inspection program. Self-inspections can be divided into several individual self-inspections of smaller scope; they should be recorded in a self-inspection report.
Take advantage of the many years of experience of our qualified experts in the QA department to draw up a self-inspection plan for your company or to carry out a self-inspection in your company.
Quality manual
SOPs & Work Instructions
Quality/Technical agreements
Job descriptions
Medicinal products imported into Switzerland from abroad must be approved by the Responsible Person (RP) of the pharmaceutical company in Switzerland before distribution. The local market release confirms that the batch complies with the Swiss marketing authorization in terms of composition, the manufacturing process, the specifications and other quality features and that it was produced in accordance with the rules of Good Manufacturing Practice (GMP).
Medicinal products imported into Switzerland from abroad must be approved for release by the responsible person (RP) of the pharmaceutical company in Switzerland before distribution. The local market release confirms that the batch complies with the Swiss marketing authorization in terms of composition, manufacturing process, specifications and other quality features, and that it was produced in accordance with the rules of good manufacturing practice (GMP).
Pharmaceutical companies must document complaints (including quality defects), returns and destruction and process them in accordance with standard operating procedures.
We can support the quality department of your pharmaceutical company in the management of complaints, returns and destruction.
Benefit from our wide range of services, our expertise and our many years of experience.
We are committed to making your projects a success in a professional, practice-oriented and time-optimized manner.
Over 20 years of experience that pays off for you.
We fully identify with your project and will find the optimum solution for you.
More than 20 years of experience as a pharmaceutical service provider
Excellent quality of work
Commitment and motivation
Professionalism
Focus on your needs
Everything from a single source
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