Soumissions réglementaires Services linguistiques

Clinical trials are expensive and multi-faceted, entailing extensive regulatory submissions and language services to support multilingual submissions. As it is very common for life science companies to outsource trials and submissions as an efficient method to reduce costs, the need for accurate and efficient language services from a trusted language service provider are also shared by organizations like CROs when conducting multilingual clinical trials.

To market a new product in Europe that was manufactured in the United States, the product may need to be translated into the 24 languages that make up the European Union as directed by the EU CTR and EU MDR policies. Before that new product can ever be marketed, there are many further obstacles to overcome, such as guidelines and regulations for each of the countries these trials are conducted in. The process of localization is complicated but critical, as mistakes can be catastrophic.

Les spécialistes mondiaux expérimentés et dévoués des services linguistiques de soumission réglementaire de CSOFT aident les entreprises à se conformer à ces exigences exigeantes en matière de documentation multilingue pour les soumissions tout en offrant la meilleure qualité linguistique.