We at STUDIO ITS provide the bilingual service for medicinal products, dealing with every single step required to draw up and publish the so-called bilingual service, FIT file (package leaflet in the German language).
- sworn translation of the package leaflet and labels;
- preparing the pdf file containing the texts of both the package leaflet and the labels in the German language as well as the image of the outer packaging of the medicinal product;
- protecting the file;
- entering the file into the UNIFARM database (where all the package leaflets of the medicinal products sold in the autonomous province of Bolzano are stored) for publication.
Obviously enough, this procedure requires full and strict compliance with the structural and formal characteristics laid down by the Managing Body (UNIFARM), and, last but not least, being trusted by the Regulatory Affairs Managers who assign us the task of delivering such a crucial service.