Medicinal products

  • pre-application consultancy
  • 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