Clinical trial documentation, pharmaceutical regulatory dossiers, medical device technical files, and patient information leaflets all carry regulatory weight. A translation error can mean a query from a health authority, a delayed submission, or in the worst case a patient safety issue. Our life sciences translators hold degrees in biology, pharmacy, medicine, or bioengineering.
We translate for pharmaceutical companies preparing EU regulatory submissions, medical device manufacturers seeking CE marking, contract research organisations managing multi-country clinical trials, and hospitals producing patient-facing materials. Our translators understand EU regulatory frameworks including the EMA guidance on clinical trial regulation, MDR 2017/745 for medical devices, and national health authority requirements across major European markets. We maintain subject-specific terminology databases for recurring clients. For clinical trial materials, we can provide certified translations accepted by ethics committees and regulatory authorities in Portugal and other EU member states. All life sciences translations are reviewed by a second subject-matter specialist before delivery.