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.
