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