Why medical translation is unforgiving
在生命科学领域，翻译错误不仅仅造成混淆——还可能造成伤害。
事关生命安全
医学翻译中的错误可能危及患者安全——从用药剂量到不良事件报告。
多市场法规要求
提交文件必须符合各目标市场的当地法规要求（FDA、EMA、PMDA）。
不断演进的术语
科学术语发展迅速——译员必须紧跟最新的命名规范和标准。
Why scientific precision is the whole job
Where a unit can endanger a patient.
A mistranslated dosage, contraindication, or adverse event description can directly affect patient outcomes. Medical translation carries a level of responsibility that no other industry matches.
- 01INN vs. brand-name driftacetaminophen ↔ paracetamol — per market
- 02MedDRA-coded adverse eventsOfficial translation, not ad-hoc equivalent
- 03Dosage units & patient instructionsmg/kg conventions vary by region
- 04IFU & consent reading-levelPatient-grade, not clinician jargon
Built for submission-grade accuracy.
Three decades of medical translation dispatch — every translator a subject-matter specialist, every safety field dual-reviewed before delivery.
- AMedDRA & INN locked glossaryPer-trial, per-market terminology
- BDual-linguist safety QATranslator + independent specialist
From submission to certified delivery
专为生命科学所要求的准确性、合规性和保密性而设计。
Document assessment
Therapeutic area, regulatory context, and target audience identified at intake — patients, physicians, or regulators.
Subject-matter linguist
Paired with translators trained in medicine, pharmacology, or biomedical science — never generalists.
Translate and adapt
Medical terminology preserved; dosage, units, and patient-facing language adapted for each target market.
Safety review
Independent specialist verifies safety information against the source — MedDRA, INN, and ICD coding double-checked.
Delivery
Final files delivered by email and through the customer portal — submission-ready or print-ready as required.
我们翻译的文件
覆盖整个生命科学流程的端到端翻译支持。
Clinical & regulatory
Trial protocols and regulatory submissions — formatted to FDA, EMA, and PMDA requirements with locked terminology.
- 临床试验文件
- 法规提交文件
- 知情同意书
- 研究论文
Pharmaceutical
Drug labeling, packaging, and patient-facing materials — INN naming and MedDRA terminology applied to every market.
- 药品标签与包装
- 患者信息手册
- 安全数据表
- Pharmacovigilance reports
Medical devices & care
Device IFUs, hospital communications, and healthcare-facing content — accuracy reviewed for patient safety.
- 医疗器械手册
- 医院通讯
- 医学报告
- 保险文件
01Do your linguists have medical or scientific backgrounds?
Yes. Every medical translator is matched to your therapeutic area and has substantial professional experience in the relevant subject matter — medicine, pharmacology, biomedical science, or device engineering. Generalists never touch medical files.
02Can you handle FDA, EMA, and PMDA submissions?
Yes. We translate eCTD modules, IBs, IMPDs, ICFs, and labeling for submissions to all major authorities. Terminology is locked to ICH guidance, INN naming conventions, and the receiving authority’s formatting requirements.
03How do you handle MedDRA-coded adverse events?
Adverse event terms are translated using the official MedDRA translations — not ad-hoc equivalents. Our QA step verifies every coded term against the current MedDRA version for the target language.
04Are you HIPAA and GDPR compliant?
Yes. NDA on every matter, HIPAA-aware workflows, GDPR data-handling for EU-sourced material, and role-based access through the customer portal. We sign your sponsor or CRO NDA on request.
05What turnaround can we expect for a clinical trial protocol?
A standard 80–120 page Phase III protocol typically runs 5–10 business days at submission grade. Patient-facing ICFs can ship in 2–3 days, and pharmacovigilance reports in 24–48 hours when locked terminology already exists.
06How are deliverables returned?
Final files are delivered both by email and through the customer portal in your required format — print-ready patient leaflets, submission-ready regulatory packages, or localized digital content. Audit trail retained for compliance.
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Project quotes return within the hour. Medical translation projects are matched by therapeutic area, audience, and regulatory context before work begins.