Pharmaceutical and medical translation operates under regulatory requirements that do not exist in other translation sectors. An incorrect term in a clinical trial protocol or a regulatory submission is not just an error: it is a compliance risk that can delay or derail a product authorisation. Our medical translators hold qualifications in pharmacology, biochemistry, medicine or biomedical engineering.
We work with pharmaceutical companies submitting to EMA, BfArM, MHRA and FDA, with medical device manufacturers meeting EU MDR and MDD requirements, and with clinical research organisations managing multi-language trial documentation. Experience covers clinical study reports, IBs, ICFs, SmPCs, PILs, drug substance and drug product dossiers.
For clients with multi-country regulatory programmes, we coordinate translation across multiple target countries simultaneously with a single project management point of contact, a central terminology database and a regulatory change tracking system.
Medical and pharmaceutical documents are scoped individually. Standard documents of 3,000 words deliver in 4 to 6 business days.