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PHARMA TRANSLATIONS

 

The vast majority of clinical studies are set in a multi-country environment, making it absolutely necessary to produce perfectly translated material to accommodate Healthcare Professionals and patients/caretakers alike.

Furthermore, translation is required for a multitude of stages in the process of developing and marketing medicinal products, including the conclusive submission of the application file to regulatory authorities. An inadequate translation may lead to delay or even the rejection of the submitted folder.

Below you will find a brief listing of some of the document types we’ve translated so far:

Pharmaceutics

  • Drug Registration Documentation
  • Instructions for Use (IFUs)
  • Package Inserts and Labels
  • Pharmacological Studies
  • Product Labels
  • Regulatory Documents
  • Adverse Events
  • Data Sheets
  • Production Manuals
  • Regulatory Documents
  • Manufacturing Process Descriptions
  • Marketing Collateral
  • NDA and IND

Clinical Trials

  • Case Report Forms
  • Development Safety Update Reports
  • Endpoint Adjudication Documents
  • Informed Consent Forms
  • Patient Diaries
  • Investigator’s Brochures
  • Patient Recruitment Materials
  • Patient Reported Outcome Measures
  • Patient Source Documents
  • Study Protocols