For pharmaceutical companies that are or want to become active in the GDP (Good Distribution Practice) field, we offer the following services:
Taking over the function of the Responsible Person (RP) respectively 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 to establish a company in Switzerland (the operating licenses are applied for according to the respective business activities such as 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