Responsible Person / Qualified Person

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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