Regulatory Submissions Language Services

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

For instance, to market a new product in Europe that was manufactured in the United States, the product may need to be translated into one of the 24 tongues that make up the European Union’s official languages, 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 in which these trials are conducted. The process of localization is complicated but critical, as mistakes can be catastrophic and could result in a product’s failure in the regulatory process or, worse, harm to its intended audience.

CSOFT’s experienced and dedicated global regulatory submission language service specialists help companies comply with these demanding multilingual documentation requirements for submissions while providing the highest linguistic quality, helping to ensure the safety of all stakeholders and customers involved.