German pharmaceutical translation – GxP-compliant and approval-ready
Pharmaceutical translation by professional translators – across Germany, fixed price from €0.95 per line, quote in about two hours.
Pharmaceutical translation: approval-ready from the study to the market launch
Pharmaceutical texts have to hold up in regulatory terms: from the SmPC through the package leaflet to the study report, we translate in an authorisation-safe, terminologically consistent way and under the four-eyes principle.
Pharmaceutical texts are strictly regulated: summaries of product characteristics and patient information leaflets, marketing authorisation dossiers, labels and clinical documents must be transferred into every target language with technical precision, terminological consistency and regulatory robustness.
Our pharmaceutical translators combine a life-science background with terminological discipline, work with the EMA's QRD templates and a project-specific glossary, and revise every version under the four-eyes principle in accordance with DIN EN ISO 17100 – strictly confidential, with an NDA on request.
Translating marketing authorisation documents and product information in QRD-compliant form
Do you translate the SmPC, package leaflet and label to the EMA QRD templates?
Yes. We transfer the summary of product characteristics (SmPC), the package leaflet (PIL) and the label into the EMA's current QRD templates. The standard phrases set out there are binding; deviating wording regularly leads to comments from the Member States during the approval procedure. We therefore work along the QRD conventions, not around them.
How do you ensure consistent terminology across all product information?
Through a project-specific glossary based on the QRD templates and a maintained translation memory. This way dosages, contraindications, interactions and side effects stay word-for-word identical between the summary of product characteristics, the package leaflet and the label – and consistent across follow-up orders and product variants.
What happens in the linguistic review in the centralised procedure?
In the centralised procedure, the product information undergoes a linguistic review in which conformity with the QRD templates and the comprehensibility of the package leaflet are assessed. We deliver the language versions so that they pass this review, and incorporate feedback on time.
Translating study documents – from the protocol to the ICF, ICH-compliant
Do you translate trial protocols, synopses and case report forms consistently?
Yes. We translate trial protocols, synopses, protocol amendments, investigator information and case report forms with consistent terminology and in line with the ICH-GCP guidelines. A fixed glossary keeps the designations stable across the entire course of the study and all country submissions.
How do you translate consent forms so they are comprehensible to laypeople?
Trial participant documents such as the informed consent form (ICF) must be understandable to laypeople and are reviewed by ethics committees. We word them clearly and appropriately for the target audience in the local language; on request we secure the back-translation where the sponsor or ethics committee requires it.
Do you code adverse events per MedDRA?
Yes. We render adverse events and conditions according to the MedDRA system so that they remain unambiguous and comparable in every language version. We also handle safety reports and periodic reports with consistent terminology and in strict confidence.
How your pharmaceutical translation works
Enquiry and upload
Send us your documents as a PDF, photo or scan – we review the scope, field and intended use.
Fixed price in 120 minutes
You receive a binding fixed-price quote with a delivery date, clearly calculated in advance.
Professional translators and revision
Assignment to professional translators with a relevant background; independent four-eyes revision in accordance with DIN EN ISO 17100.
Delivery digital and by post
Digital advance version and, on request, the hard copy by post – on schedule.
Pharmaceutical translation: German, English, French, Turkish, Spanish, Polish and over 60 languages
We deliver pharmaceutical translations in German, English, French, Spanish, Italian and over 60 further languages – by professional translators with a life-science background. Terminology, MedDRA coding and citation style remain consistent.
How your fixed price for a pharmaceutical translation is calculated
We bill transparently by standard line (55 characters including spaces) from €0.95. The binding fixed price depends on volume, field, language combination and the desired quality level – with no hidden costs and usually within about two hours. View prices and sample calculations.
Pharmaceutical translation – frequently asked questions
What does a pharmaceutical translation cost?
From €0.95 per standard line; the binding fixed price depends on volume, field, language combination and quality level, and usually reaches you within about two hours.
Do you translate per EMA QRD templates?
Yes. We render product information such as SmPC, package leaflet and label into the EMA's current QRD templates; we code adverse events consistently per MedDRA.
Who translates pharmaceutical texts?
Native-speaker professional translators with a life-science background; every version is revised independently in accordance with DIN EN ISO 17100.
Can you handle clinical trial documents?
Yes. We translate study plans, consent forms (ICF) and study reports in a terminologically consistent way and in line with the ICH guidelines.
How do you ensure confidentiality?
Strictly confidential and GDPR-compliant, with an NDA on request; access only for the project team.
Pharmaceutical translation per GxP and EMA requirements
Pharmaceutical texts have to be regulatorily sound: product information follows the EMA's QRD templates, adverse events are coded per MedDRA, clinical documents per the ICH guidelines. We translate Package leaflets, Valuation reports, Study documents and Intellectual property rights – authorisation-safe, under the four-eyes principle in line with DIN EN ISO 17100 and strictly confidential.