We provide regulatory services with a team of highly qualified experts specialised in the field of regulation of human and veterinary medicinal products. In the field of registration of medicinal products, we perform all activities necessary for the placement of the medicinal products on the market as well as activities necessary for the maintenance of marketing authorisations:
- National Procedures (NP), Mutual Recognition Procedures (MRP) and Decentralised Procedures (DCP) – new application, extension, renewal, variations of marketing authorisation and notification.
- Centralised Procedures (CP):
- preparation and review of translations of the product information (SmPC, PIL, labelling) in accordance with the QRD and national requirements;
- advice on local specificities;
- preparation of blue-box applications.
- artwork review (proofreadings),
- review of marketing material,
- preparing applications for an exemption to the obligation of labelling a medicinal product in the Slovene language, for individual deviation from the terms of marketing authorisation and for the sunset clause,