Quality Assurance

For pharmaceutical companies that are or want to become active in the GDP field, we offer the following services:

• Taking over the function of the technically responsible person (Qualified Person · QP) or his/her deputy
• Taking over the function of marketing authorization holder for companies not having a pharmaceutical operating license in Switzerland
• Application for pharmaceutical operating licenses according to the type of approval required for the respective business activities (import, export, wholesale, trade abroad)
• Establishment and maintenance of a quality management system (QMS)
• Drafting, reviewing and updating GxP contracts

• Carrying out QA tasks on behalf of or as a function of the local FvP (e.g. batch release, processing of complaints, deviations and CAPAs, returns, etc.)

• Assistance before, during and after authorities’ inspections
• Preparation and execution of audits
• Evaluation of Product Quality Reviews (PQRs)

•  Consultation and training