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) including batch release, as well for narcotics and vaccines
• Taking over the function of the 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 perpetuation/maintenance of a quality management system (QMS)
• Development, review and update of standard operating procedures (SOPs) and GxP contracts
• Assistance before, during and after authorities’ inspections
• Audit preparation and execution
• Evaluation of Product Quality Reviews (PQRs)
• Answering product-related medical inquiries from healthcare professionals
• Support in pharmacovigilance activities
• Training in quality assurance including pharmacovigilance