With a good quality management system, you ensure that your products and processes comply with the required level of quality and 鈥済ood practice鈥� standards 鈥� 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)
聽If required, we assume the function as your company鈥檚 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:
- 聽 聽Obtaining an Establishment license in Switzerland
- 聽 聽Evaluation of the required types of permits for your company
If required, we offer the use of our聽establishment licenses聽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:
- 聽 聽Evaluation and optimisation of existing quality management systems
- 聽 聽Implementation of new quality management systems