Pharmaceutical Translation Â鶹APP
Accurate, regulation-ready pharmaceutical translation for drug developers, manufacturers, and CROs. The Translation Company is a women-owned (WBENC-certified) US firm that has translated pharmaceutical and life sciences content since 2005 — drug labels, package inserts, regulatory submissions, and pharmacovigilance reports — for the FDA, the EMA, and markets worldwide. In pharma, an inaccurate translation can stall a submission, trigger a recall, or put a patient at risk.
Operating to ISO 9001 and ISO 17100 standards · Women-owned (WBENC) · Serving regulated teams since 2005 · Last updated June 2026
— a working session about your program, not a sales pitch.
Why pharmaceutical translation is different
The pharmaceutical industry is a global branch of the life sciences, and that global reach is what makes new medicines viable: development and testing are enormously expensive, so a drug has to reach many markets to justify the investment. Reaching those markets accurately is the job of pharmaceutical translation — and accuracy here is non-negotiable. A mistranslated dosage on a label, an unclear instruction in a package insert, or an error in a regulatory submission can ruin a study, delay an approval, or harm a patient. Many pharmaceutical terms exist only in the language in which they were first described, so a qualified linguist must render the concept precisely rather than guess at it.
Pharmaceutical documents we translate
We translate across the full drug lifecycle, for sponsors, manufacturers, and CROs:
- Drug labels, packaging, and summaries of product characteristics (SmPCs)
- Patient information leaflets (PILs) and package inserts
- Regulatory submissions and dossiers (FDA and EMA)
- Pharmacovigilance and safety reports (PSURs, ICSRs)
- Clinical protocols, case report forms, and informed consent forms
- Patents and CMC (chemistry, manufacturing, and controls) documentation
- Manufacturing SOPs and batch records
- Training materials and marketing-authorization correspondence
Regulatory compliance: FDA, EMA, and beyond
Getting a drug to market means meeting each authority’s language requirements. We align our pharmaceutical translation to the frameworks our clients answer to — the FDA, the European Medicines Agency (EMA) and its QRD product-information templates, EU requirements to provide labeling and leaflets in national languages, 21 CFR Part 11, and Good Practice (GxP) expectations. For safety content, our pharmacovigilance translation keeps adverse-event and periodic-safety reporting accurate and on schedule. When a document needs certification, we provide a signed certificate of accuracy.
Across the drug lifecycle
From early R&D and clinical trials through marketing authorization and post-market safety, we keep terminology consistent across every document and every market. Once a drug is approved, leaflets and inserts have to be localized flawlessly for each country where it is sold — because when a medicine can be dangerous if used incorrectly, each word has to be exact. We build and enforce a product glossary so the same approved terms are used from the first protocol to the final label. That consistency is what keeps a global pharmaceutical translation program accurate and audit-ready as products, indications, and labels change over time.
Why pharma teams choose us
- Women-owned and WBENC-certified. A real advantage for pharmaceutical supplier-diversity programs.
- Principal-level accountability. You deal with ownership, not a rotating account manager, and qualified buyers can speak with our CEO directly.
- Human expertise, AI used with judgment. Technology assists; a subject-matter linguist translates and a second reviews. Confidential data is never pushed through public machine-translation tools.
- Quality you can document. Processes that operate to ISO 9001 and ISO 17100 standards, with a certificate of accuracy on request.
- Faster turnaround. We consistently deliver 30–50% faster than the industry standard, without skipping review.
Regulatory submissions and pharmacovigilance
Pharmaceutical translation is governed by templates and terminologies, not just language pairs. Product information for the EU — the summary of product characteristics (SmPC), labeling, and package leaflet — follows the EMA’s QRD (Quality Review of Documents) templates and is produced in all 24 official EU languages for a centrally authorized medicine, where a single mistranslation can hold up a marketing authorization. Package leaflets also have to read clearly enough for patients, so readability matters as much as accuracy. On the safety side, we translate the pharmacovigilance record — individual case safety reports (ICSRs), periodic safety update reports (PSURs), and signal documentation — using MedDRA terminology, which both the EMA and the FDA require, so adverse events are coded consistently across every language. We prepare files to slot into your eCTD submission, with the audit trail and version control regulated work demands.
Frequently asked questions
Do drug labels and inserts need certified translation?
Regulators require accurate, complete translations of labeling and patient leaflets, and many submissions call for a certificate of accuracy. We provide certified pharmaceutical translation whenever it is required.
Do you handle EMA language requirements?
Yes. We translate product information to the EMA’s QRD templates and into the EU national languages a marketing authorization requires.
Can you support pharmacovigilance reporting?
Yes. We translate ICSRs, PSURs, and related safety documents accurately and on the timelines pharmacovigilance demands.
How do you keep terminology consistent?
We build and enforce a product glossary and translation memory before drafting, so approved terms stay consistent across labels, inserts, submissions, and updates.
Which languages do you cover?
The languages your markets and authorities require, across Europe, Asia, the Middle East, and the Americas, plus many more.
Explore related services
- Medical & life sciences translation — our full medical translation practice.
- Clinical trial translation — protocols, ICFs, CRFs, and linguistic validation.
- Medical device translation — IFUs and labeling under EU MDR and IVDR.
Talk with us about your pharmaceutical program
Start with a conversation, not a price tag. , best suited to drug developers and manufacturers looking for a long-term partner. Have documents ready? Email [email protected] or call 800.725.6498.