Medical Translation

Protocolos de ensayos clínicos, formularios de consentimiento informado, documentos IFU, presentaciones regulatorias y documentación farmacéutica — traducidos por lingüistas con formación científica y médica.

El Desafío

Why medical translation is unforgiving

3 risks · audited per project

En ciencias de la vida, los errores de traducción no solo causan confusión, pueden causar daño.

Hay Vidas en Juego

Los errores en traducciones médicas pueden poner en peligro la seguridad del paciente — desde instrucciones de dosificación hasta reportes de eventos adversos.

Dual review100%

Exigencias Regulatorias en Múltiples Mercados

Las presentaciones deben cumplir con los requisitos regulatorios locales (FDA, EMA, PMDA) de cada mercado objetivo.

AuthoritiesFDA · EMA · PMDA

Terminología en Constante Evolución

La terminología científica evoluciona rápidamente — los traductores deben mantenerse actualizados con la nomenclatura y los estándares más recientes.

MedDRA + INNLocked
La terminología importa

Why scientific precision is the whole job

Two questions, answered →
The risk

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
Our delivery

Built for submission-grade accuracy.

Three decades of medical translation dispatch — every translator a subject-matter specialist, every safety field dual-reviewed before delivery.

100%
Term accuracy on medical corpus
120+
Languages active
30+
Years dispatching medical translators
HIPAA
HIPAA-aware workflow
  • AMedDRA & INN locked glossaryPer-trial, per-market terminology
  • BDual-linguist safety QATranslator + independent specialist
How it works

From submission to certified delivery

 

Diseñado para la precisión, el cumplimiento y la confidencialidad que exigen las ciencias de la vida.

01Intake

Document assessment

Therapeutic area, regulatory context, and target audience identified at intake — patients, physicians, or regulators.

02Matching

Subject-matter linguist

Paired with translators trained in medicine, pharmacology, or biomedical science — never generalists.

03Translation

Translate and adapt

Medical terminology preserved; dosage, units, and patient-facing language adapted for each target market.

04QA

Safety review

Independent specialist verifies safety information against the source — MedDRA, INN, and ICD coding double-checked.

05Delivery

Delivery

Final files delivered by email and through the customer portal — submission-ready or print-ready as required.

Document types

Documentos que Traducimos

Submission-grade

Soporte de traducción integral en toda la cadena de ciencias de la vida.

Clinical & regulatory

Trial protocols and regulatory submissions — formatted to FDA, EMA, and PMDA requirements with locked terminology.

  • Documentos de ensayos clínicos
  • Presentaciones regulatorias
  • Formularios de consentimiento informado
  • Artículos de investigación
FDA · EMA · PMDA · ICH

Pharmaceutical

Drug labeling, packaging, and patient-facing materials — INN naming and MedDRA terminology applied to every market.

  • Etiquetado y empaque de medicamentos
  • Prospectos informativos para pacientes
  • Hojas de datos de seguridad
  • Pharmacovigilance reports
MedDRA · INN · per-market

Medical devices & care

Device IFUs, hospital communications, and healthcare-facing content — accuracy reviewed for patient safety.

  • Manuales de dispositivos médicos
  • Comunicaciones hospitalarias
  • Informes médicos
  • Documentos de seguros
IFU · ISO 13485 aligned
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.

Start a project

Upload your file and get your instant quote
in seconds.

Project quotes return within the hour. Medical translation projects are matched by therapeutic area, audience, and regulatory context before work begins.

Quote
Instant
Languages
120+ active
Review
Medical QA
Delivery
Submission ready