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Translations of Regulatory Documents

Today’s biomedical and health-care companies face a challenging task—to develop multilingual documentation and labeling that meets regulatory standards and support the company’s communication objectives for products that are being introduced within ever-shorter launch cycles. Meeting this challenge represents one of Global Link’s key areas of expertise.

At Global Link, we provide medical translation services to a wide range of multilingual medical communications. Our adaptation and production process includes careful translation and review by medical experts and by our client’s in-country representatives, as well as ongoing glossary development to ensure consistent use of medical terminology. In compliance with regulatory requirements, Global Link certifies all foreign-language versions of medical product labeling and technical medical documentations. In addition, Global Link offers back translation and verification processes of all their medical translations.

Our experience in the area of medical translation services include:

Types of Medical Documents We Translate

  • Case Report Forms (CRF)
  • Clinical Protocols
  • Clinical Trials
  • Data Sheets
  • Dossiers
  • Drug Registration Documentation
  • Informed Consent Forms
  • Instructions for Use (IFU)
  • Manufacturing Process Descriptions
  • Package Inserts and Labels
  • Patient Information
  • Patient Questionnaires
  • Pharmacological Studies
  • Product Labels
  • Production Manuals
  • Regulatory Documents
  • Scientific Papers
  • Toxicology Reports