Responsible Person / Qualified Person

We are a team of Responsible Persons and Quality Managers with extensive experience in the delivery of services for customers focusing on Good Manufacturing Practice (GMP) and Good Distribution Practices (GDP).

Services

• Responsible Person (RP) and deputy-RP function for the Swiss market
• Compliance in accordance with Swiss laws
• Responsible Person for controlled substances
• Contact Person for the Swiss authorities
• Batch releases for Switzerland and Liechtenstein
• Review and release of promotional material
• Lead/support with authority inspections
• Management of complaints, quality defects and CAPAs
• Handling of returns and batch recalls
• Evaluation of product quality reviews (PQRs)
• Preparation of technical/quality agreements
• Performance of audits
• Support and assistance in risk management