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Certified Pharmaceutical Document Translation
Get your pharmaceutical document translated into English by a professional human translator, with a signed certification accepted by USCIS, courts and universities. Flat $24.95 per page and a 100% USCIS acceptance guarantee.
$24.95/page
Flat rate per page, up to 250 words. No hidden fees.
100% USCIS acceptance
Every certified translation is guaranteed to be accepted by USCIS.
24-hour delivery
Most 1-3 page documents are delivered within 24 hours. Same-day available.
Dossiers, certificates and the paperwork of getting a product in
Bringing a medicine, a device or an ingredient into the United States means putting foreign-language documentation in front of American reviewers, auditors and customers:
- Manufacturing licences and GMP certificates issued by a foreign regulator
- Certificates of pharmaceutical product, free sale certificates and marketing authorisations
- Certificates of analysis, batch records and stability data
- Standard operating procedures and validation reports requested during an inspection
- Summaries of product characteristics, package inserts and labelling
- Supplier qualification files and quality agreements
Numbers, units and names exactly as issued
Strengths, concentrations, batch numbers, expiry dates, licence and authorisation numbers and analytical results are reproduced precisely, in the units the original uses. An active ingredient is rendered by the name the document gives it, with the international nonproprietary name alongside where that helps a reviewer, rather than replaced by the US brand name of what a translator assumes is the same product.
Regulatory categories keep their own names too. A European marketing authorisation is not an FDA approval, and translating it as though it were would assert a regulatory status the document does not confer.
What a translation does and does not settle
We translate the documents and certify the translations. What a US regulator requires, in what format, and whether a foreign certificate satisfies it are questions for your regulatory affairs team or counsel — a translation makes a document readable, it does not make it sufficient.
If the product is also being imported, the customs paperwork has its own English requirement under 19 CFR 141.86(d), and it is a separate document set.
How it works
Upload a photo or a scan of your document, pick the language pair and check out online. You never have to mail originals: a legible copy is all we need.
A professional human translator, never machine translation, translates the document word for word and mirrors the layout of the original. Every certified translation ships with a signed Certificate of Translation Accuracy that meets the requirements of USCIS, courts and universities.
Your translation is delivered digitally, usually within 24 hours for documents of one to three pages, and same-day delivery is available. If anything needs adjusting, we revise it.
Certified vs. standard translation
A certified translation is a word-for-word translation accompanied by a signed statement attesting to its accuracy and completeness. It is what official bodies require: USCIS, courts, universities and government agencies. Certified translations are $24.95 per page, where a page is up to 250 words.
A standard translation is for business or personal use where certification is not needed, such as CVs, client intake forms or marketing material, and is billed at $0.10 per word.
Frequently asked questions
Do you translate a European marketing authorisation into its FDA equivalent?
No. Regulatory categories keep their own names. Presenting a foreign authorisation as an FDA approval would assert a status the document does not confer.
Can you handle a long dossier?
Yes. Long technical documents are often better quoted as standard translation at $0.10 per word, unless the recipient requires certification. Ask before ordering.
Are batch numbers and analytical values reproduced exactly?
Yes, digit for digit and in the original units, so the translation reconciles against the certificate it came from.
Ready to get started?
Upload your documents and receive your certified translation, typically within 24 hours.