Registration of medicines

We offer service of registration, renewal of registration, notification of variation for a medicine under the requirements of the regulatory authorities:

•    Preparation of a registration file in accordance with local requirements and submitting the application for registration;
•    Preparation of a draft version of the Summaries of Product Characteristics (SmPC), the Package Leaflet (PIL) and the text for the outter and inner packaging of the drug (labelling);
•    Monitoring of the registration process or registration renewal process until the market license is obtained;
•    Activities related to the maintenance of current registrations – preparation, submission and monitoring of registration renewal requests as well as variations for registered medicinal product.