Regulatory Affairs

Regulatory Affairs support includes:

  • advice in setting up of registration strategies;
  • support in implementation of registration strategies;
  • support in registration of medicinal products/food supplements/medical devices;
  • support in maintenance of the validity of the marketing authorizations during life cycle of the products;
  • support in proper implementation of variations to the terms of the marketing authorization in order to preserve the “regulatory compliance”;
  • management of MRP, DCP, centralised and national procedures in the terms of marketing authorization applications, renewals, variations;
  • preparation of documentation in eCTD or NeeS format, validation and electronic submission of applications via CESP platform;
  • support in preparation and update of product information materials;
  • representation of the marketing authorisation holder towards the competent authorities (representative of the marketing authorisation holder);
  • consultations with competent authorities;
  • consultations with experts;
  • project management;
  • support in all activities related to parallel import.