Academic & Research

About this service

Medical and pharmaceutical translation carries a regulatory responsibility that most translation categories do not. A patient information leaflet that uses ambiguous language about a side effect can have direct patient safety consequences. An EMA regulatory submission that does not follow the correct linguistic conventions for the applicable dossier type risks a validation rejection. A clinical trial protocol where the dosage instructions are not translated with complete precision creates a patient safety risk in the trial. The stakes are fundamentally different from commercial translation.

Our medical and pharmaceutical translators have life sciences academic backgrounds. This means they understand not just the vocabulary but the conceptual framework behind the text. They know the difference between a Phase I and Phase II trial structure, how a Summary of Product Characteristics is organised, what the Declaration of Conformity for a medical device must contain, and how the ICH guidelines shape the expected language of regulatory submissions.

We have particular depth in Italian-English-German translation for pharmaceutical regulatory documents, which reflects the major European regulatory pathways. For medical device documentation under the EU MDR, we work with the specific language and documentation structure requirements of the regulation. For clinical trial documents, we maintain alignment with the EMA clinical terminology glossary and the relevant ICH guidelines for each document type.

For clients with ongoing translation requirements across a clinical programme or regulatory cycle, we offer retainer arrangements with guaranteed capacity during intensive documentation phases and a maintained programme glossary that ensures terminology consistency across every document.