ISO 17100 Certified Β Β·Β  ITI Member Β Β·Β  CIOL Listed Β Β·Β  UKVI Accepted Β Β·Β  Security-Vetted Translators Available Β Β·Β  London, UK β€” Est. 2011

ISO 17100 Certified Β Β·Β  ATA Member Β Β·Β  NAJIT Member Β Β·Β  USCIS Accepted Β Β·Β  Security-Cleared Translators Available Β Β·Β  Miami, FL β€” Est. 2011

US USA GB UK
US USA GB UK

Translation Services for Healthcare & Pharmaceuticals

The healthcare and pharmaceutical industries operate under regulatory frameworks where translation accuracy is a patient safety requirement. An FDA submission with incorrectly translated clinical data can delay drug approval. A mistranslated patient information leaflet can cause medication errors. A clinical trial protocol translated without ICH-GCP rigour can compromise trial integrity.

Translation AZ serves pharmaceutical companies, hospitals, health systems, CROs, medical device manufacturers, and biotech firms with certified medical and pharmaceutical translation. Every medical translation is performed by a linguist with clinical or life sciences expertise.

Documents We Translate

πŸ”¬

Clinical trials

Protocols, ICFs, CRFs, PROMs, CSRs, adverse event reports, and IRB/REC submissions

πŸ’Š

Regulatory submissions

FDA IND, NDA, ANDA, 510(k), PMA, BLA submissions, and labeling

🏷️

Pharmaceutical labeling

USPI, medication guides, Drug Facts labels, and packaging

πŸ₯

Medical devices

IFUs, device labeling, technical files, 510(k) and PMA documentation, and clinical evaluation reports

πŸ“‹

Patient records and medical reports

Discharge summaries, pathology reports, radiology reports, medical histories

✍️

Informed consent and patient materials

Consent forms, patient education, health literacy materials, and hospital signage

πŸ“Š

Healthcare compliance

HIPAA policies, Joint Commission documentation, CMS compliance

Why Healthcare Organisations Choose Translation AZ

πŸ”¬

Clinical and life sciences expertise β€” Translators with backgrounds in medicine, pharmacy, nursing, and biomedical sciences

πŸ“‹

Linguistic validation β€” Full linguistic validation workflow for PROMs and COAs: forward translation, back-translation, cognitive debriefing, harmonisation

πŸ”’

HIPAA compliance β€” Business Associate Agreements, encrypted handling, HIPAA-trained staff

πŸ“

DTP for pharmaceutical packaging β€” Multilingual labeling with text expansion management, print-ready file delivery

⚑

Safety report urgency β€” Expedited turnaround for adverse event reports and safety-critical translations

πŸ›‘οΈ

Insurance coverage β€” Professional Liability and Cyber Liability insurance for healthcare translation

How It Works

STEP 01

Submit your documents

Upload through our secure, encrypted quote form. Include the regulatory context and therapeutic area.

STEP 02

Quote within 2 hours

With specialist linguist assignment and regulatory compliance confirmation.

STEP 03

Translation and review

Clinical/pharmaceutical specialist with independent review. PROMs undergo full linguistic validation.

STEP 04

Certified delivery

Version-controlled, regulatory-formatted, with certification.

2-Hour Quote Response β€” Standard 24–72 hrs Β· Rush available

Need Healthcare or Pharmaceutical Translation?

Submit your documents for a free quote. We respond within 2 hours.

Frequently Asked Questions

Yes. Our medical translators hold qualifications or demonstrated expertise in medicine, pharmacy, nursing, biomedical sciences, or related fields.

Yes. Business Associate Agreements, encrypted transmission, and HIPAA-trained staff.

Yes. We support FDA submission timelines with expedited turnaround for regulatory-critical documents.

Yes. Full linguistic validation: forward translation, reconciliation, back-translation, clinician review, cognitive debriefing, and harmonisation.