Pharmaceutical Translation
Translation of regulatory submissions, foreign labeling, clinical trial documents and patient information for drug sponsors and their partners.
The short answer
FDA submissions must be in English: an NDA must include an accurate and complete English translation of any part not in English, or FDA may refuse to file it (21 CFR 314.101), and INDs carry the same requirement (21 CFR 312.23(c)). Drug labels sold in the US are in English, and any foreign-language label must repeat all required information (21 CFR 201.15(c)).
Rules that apply
Each rule links to its source. Checked 4 November 2026. Rules change, so confirm with the office that will receive your documents.
| Rule | Source |
|---|---|
| FDA may refuse to file an NDA that lacks an accurate and complete English translation of each part not in English. | 21 CFR 314.101 |
| An IND must include an accurate and complete English translation of each part not in English, and a copy of each original publication translated. | 21 CFR 312.23(c) |
| Required drug labeling must be in English; if a foreign language is used, all required statements must also appear in it. | 21 CFR 201.15(c) |
| Informed consent information must be in language understandable to the subject. | 21 CFR 50.20 |
| EU labelling and package leaflet particulars must appear in the official language or languages of the member state where the product is marketed. | Directive 2001/83/EC, Article 63(1) |
Where translation enters a drug's life
Development: foreign study reports, literature, investigator brochures and correspondence with foreign regulators, all of which must be translated into English for an IND or NDA. Clinical trials: protocols for foreign sites, informed consent forms, patient diaries and questionnaires, translated out of English into each site's languages. Marketing: foreign labeling submitted to FDA for comparison, US labeling translated for other markets, and safety reports from abroad.
Translations FDA will rely on
A translation in a submission is part of the application. It has to be complete (no summarising of sections the sponsor considers unimportant), accurate, and traceable to the original page. We keep the structure of the source document, translate tables cell by cell, keep units and reference ranges as written, and deliver a certificate of accuracy for each document. FDA reviewers have issued complete response letters asking for certified translations of foreign labeling that was submitted without them; it is cheaper to provide them the first time.
Consent forms and trial documents
Consent forms are translated into the language of each participant group, with the reading level kept close to the English. Ethics committees usually want a certificate of accuracy, and some want a back-translation; ask your IRB. Questionnaires used as endpoints may need linguistic validation with patient interviews, which is a separate process we do not run.
Terminology
International nonproprietary names (INNs) are used for active substances, and brand names are kept as they appear. Pharmacopoeial references (Ph. Eur., USP, JP) stay as cited. Adverse event terms follow the MedDRA terms used in the source where they can be identified; we do not re-code events.
EU product information
For the EU, the summary of product characteristics, labeling and leaflet follow the EMA's QRD templates in each language, and each member state's official language applies. If you have approved QRD translations from a previous procedure, send them so the new text matches.
Safety information from abroad
Post-marketing safety reporting covers adverse experiences from foreign sources as well as US ones, and foreign case reports, literature articles and regulator communications often arrive in other languages. Speed matters because reporting clocks are short. We translate case narratives, lab values and dates exactly, keep patient identifiers as they appear in the source, and flag anything ambiguous for your safety physician rather than resolving it.
What we don't do
We translate; we do not prepare regulatory submissions, code adverse events, run linguistic validation studies, or act as a regulatory agent.
Documents we translate for this
Medical Records translation
Certified translation of medical records, vaccination records and reports for treatment, immigration medicals and insurance claims.
User Manual translation
Translation of user manuals, instructions and quick-start guides for products sold in the US, the EU, Canada and elsewhere, following each market's …
Price
$39 for the first page (up to 250 words) into English, $49 into any other language, then $0.116 per additional word. Each file is priced on its own. The signed certificate of accuracy is included.
Full pricingTurnaround
24 hours standard for most documents. Expedited service is +50% for 6–8 hours and +100% for 1–3 hours. Large files are quoted with a delivery date before you pay.
Questions
Do you translate foreign literature for an IND?
Yes. 21 CFR 312.23(c) asks for an accurate and complete English translation and a copy of each original publication translated, so send the full article.
Can you translate foreign adverse event reports quickly?
Yes. Short case reports can be delivered in hours with expedited service. Tell us the reporting deadline when you send them.
Does FDA require certified translations?
The rules require accurate and complete English translations. FDA reviewers often ask for certified translations of foreign labeling, so a signed certificate is the safe choice. Ours include one.
Do you translate clinical trial consent forms?
Yes, into each participant language, with a certificate of accuracy for the IRB.
Can you work from approved EU QRD translations?
Yes. Send the previously approved versions and we keep their wording for unchanged text.
Related
Prepared by Global Certified Translations, Edgewater, NJ. Translations are signed by a State Court Certified Translator. This page explains translation requirements; it is not legal advice.
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