acting as a local contact during marketing authorization process (national authorizations, MRP, DCP)
preparation of local documents requested to apply for granting marketing authorization including quality translations of SmPC, PI and labelling in accordance with valid QRD
local support during the life-cycle of medical products: variations to marketing authorization, renewal of marketing authorization and other activities relating to legal obligations of Marketing Authorization Holder
Pharmacovigilance
acting as a local person responsible for pharmacovigilance in the Czech Republic
contacts between the client and national competent authority
translation of local safety reports and timely reporting to the client
maintaining SOPs covering all steps of local pharmacovigilance
Medical devices
consultations concerning the notification duty applicable to medical devices in the Czech Republic
registering the client into the Czech registry of medical device distributors
notification of food supplements in the Czech registry of medical devices
preparation of Czech labelling and handling instructions
Food supplements
consultations concerning the notification duty applicable to food supplements/foods for special medical purposes in accordance with the effective laws of the Czech Republic
preparation of the Czech labelling
communication to the Ministry of Health/Ministry of Agriculture on behalf of the client