Regulatory affairs of medicinal products

Services relating to obtaining marketing authorisations of medicinal preparations, their renewals, type IA, IB, and II variations, and changes not attributed to variations:

• presentation of detailed information about the requirements of the laws of the Republic of Lithuania and the EU, advice on medicinal product introduction to the market;
• presentation of the common technical document (CTD) / regulatory affairs file for the medicinal preparation;
• review and evaluation of the file for the medicinal preparation prepared by the client;
• completion of applications for the issue of marketing authorizations, their renewal, variations, preparation of necessary documents and submission of ready files to the State Medicines Control Agency under the Ministry of Health, process management;
• representation of the marketing authorisation holder and manufacturer in dealing
• with the State Medicines Control Agency under the Ministry of Health;
• translation of summaries of product characteristics, package leaflets, and labelling.