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
Clinical trials
Protocols, ICFs, CRFs, PROMs, CSRs, adverse event reports, and IRB/REC submissions
Regulatory submissions
FDA IND, NDA, ANDA, 510(k), PMA, BLA submissions, and labeling
Pharmaceutical labeling
USPI, medication guides, Drug Facts labels, and packaging
Medical devices
IFUs, device labeling, technical files, 510(k) and PMA documentation, and clinical evaluation reports
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
Healthcare compliance
HIPAA policies, Joint Commission documentation, CMS compliance
Why Healthcare Organisations Choose Translation AZ
Clinical and life sciences expertise
Translators with backgrounds in medicine, pharmacy, nursing, and biomedical sciences
Linguistic validation
Full linguistic validation workflow for PROMs and COAs: forward translation, back-translation, cognitive debriefing, harmonisation
HIPAA compliance
Business Associate Agreements, encrypted handling, HIPAA-trained staff
DTP for pharmaceutical packaging
Multilingual labeling with text expansion management, print-ready file delivery
Safety report urgency
Expedited turnaround for adverse event reports and safety-critical translations
Insurance coverage
Professional Liability and Cyber Liability insurance for healthcare translation
How It Works
Submit your documents
Upload through our secure, encrypted quote form. Include the regulatory context and therapeutic area.
Quote within 2 hours
With specialist linguist assignment and regulatory compliance confirmation.
Translation and review
Clinical/pharmaceutical specialist with independent review. PROMs undergo full linguistic validation.
Certified delivery
Version-controlled, regulatory-formatted, with certification.
Need Healthcare or Pharmaceutical Translation?
Submit your documents for a free quote. We respond within 2 hours.