Drug Information Translation

Patient information leaflets, summaries of product characteristics, package inserts, and safety data sheets must be accurate and compliant with regulatory requirements in every target market. Even small inaccuracies in dosage, side effects, or drug interactions can endanger patient safety and delay market approval.

BeTranslated has translated pharmaceutical and medical texts since 2002, with native specialist translators familiar with terminology standards such as MedDRA and the EMA's QRD templates. Every translation goes through review under the four-eyes principle.

Accurate translation of drug information is critical for patient safety: patients need to know exactly how to take their medication to avoid risk. Translation is also required to meet the legal requirements of each target country, since a medicine can only be approved and sold in international markets this way.

Translating drug information is a demanding task: technical terms must be translated correctly and consistently, cultural and linguistic differences between target markets have to be accounted for, and often very tight deadlines have to be met without compromising quality.

Advisory boards and pharmacovigilance meetings with international experts can be supported by our consecutive and simultaneous interpreting. If a regulator such as the EMA, a national medicines agency or the FDA asks for a certified version of a leaflet or label, we can supply official certified translations.