Our services

We are a team of pharmaceutical experts offering tailored made services focused on but notlimited to:

            • Regulatory service
                           • preparation and update of registration documentation for medicinal products tailored toyour company
                           • regulatory support within EU in line with your company requirements
                           • management of registration procedures within EU
                           • preparation and update of local translations of Summary of Product Characteristics (SmPC),Patient Information Leaflet (PIL) and
                              Labelling (LAB)
                           • review of mock-up or artwork content and compliance according to REG-9
                           • monitoring of local legislation
            • eCTD compilation
                           • complete eCTD maintenance of your product portfoli

            • Implementation of Global SOPs into local procedures based on knowledge of your activitiesand the legal requirements
               of the Czech Republic

            • Preparation and updates of Standard Operating Procedures (GMP/GDP non-sterile products)

            • Support in obtaiting permits in the areas of GDP or GMP (non-sterile products, import)

            • Market Access
                           • full complex support for the Czech republic from registration to distribution of medicinalproducts
                           • Ensuring price determination and reimbursement from health insurance (for reimbursedmedicines) and inclusion in the List of
                             Reimbursed Medicines.