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Medical Translation

FDA / EMA / NMPA Ready

FDA / EMA / NMPA Ready

Clinical and regulatory translations that meet the most stringent global health authority requirements.

What We Handle

  • Clinical trial protocols and reports
  • Instructions for Use (IFUs) and labeling
  • Regulatory submissions (IND, NDA, 510k)
  • Patient-reported outcomes (PROs)
  • Informed consent forms (ICFs)

Compliance Standards

We adhere to ISO 13485 for medical devices, ICH E6 for clinical trials, and maintain full traceability with audit-ready documentation for every project.

Therapeutic Areas

Oncology, cardiology, neurology, immunology, orthopedics, ophthalmology, and diagnostics. We maintain specialist pools across all major therapeutic areas.

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