Patient Information Leaflets and Package Inserts
Accurate, patient-readable translation of dosage, side effect, and interaction information.
Translation for Approval and Patient Safety
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.
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We have 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.
What We Translate for Drug Information
Summaries of Product Characteristics and Safety Data Sheets
Translation to terminology standards such as MedDRA and the EMA's QRD templates.
Target-Market Localization
Adaptation to each market's linguistic, cultural, and health-regulation requirements. Product documents that a state court, a European national medicines agency, or a hospital asks to see in translation can be delivered as certified translations, with a signed certificate of accuracy.
SEO Translation for Medical Portals
Optimized translation for online portals that provide medical information, so products can be found in each target market.
What Our Clients Say
“Reliable, trustworthy and customer-centric This is the summation of Michael, Suzy and their team of translators.”
Calypso R.Google review (INTL), 6 years ago “A proactive company, willing to help. I recommend them for website translation and SEO in multiple languages. In my case it was with the WPML plugin.”
David L. C.Google review (SL), 2 months agoTranslated from Spanish “I’ve collaborated with this translation agency for a long time and continue to be satisfied with the quality of their services. A dependable partner for multilingual…”
Marianne W.Google review (INTL), 10 months ago
Frequently Asked Questions
What counts as drug information?
This includes patient information leaflets, summaries of product characteristics, package inserts, and safety data sheets covering dosage, side effects, interactions, and storage.
Which terminology standards do you use?
Our translators work to standards such as MedDRA and the EMA's QRD templates, and every translation is reviewed under the four-eyes principle.
4.96/5.0 from 178 Google reviews
Ready for Your Pharmaceutical Translation?
Contact us for a translation quote. We will handle your pharmaceutical translations reliably and on schedule.
- Pharma terminology
- Four-eyes review
- Confidential handling