Pharma

Specialised translation services for the complete spectrum of clinical trial documentation, ensuring regulatory compliance and scientific accuracy across all materials required for successful study conduct and submission.

Patient Information Leaflets (PIL)

Translation of PILs with focus on clarity, readability, and patient comprehension, while maintaining full alignment with regulatory requirements and approved source content.

Pharmacovigilance Documentation

Translation of safety reports, and vigilance forms in line with EU regulatory frameworks.

Summaries of Product Characteristics (SmPC)

Accurate translation of SmPCs in accordance with EMA/QRD templates and EU pharmacovigilance standards. Terminology harmonised for consistency across regulatory submissions and related documentation.

  • Study protocols and amendments
  • Informed Consent Forms (ICF)
  • Case Report Forms (CRF)
  • Clinical Study Reports (CSR)
  • Investigator’s Brochures
  • Ethics Committee/IRB approvals

  • Study Monitoring Plans
  • Medical and laboratory procedures
  • Investigational product handling instructions
  • Master randomisation lists
  • Shipping records and adverse event reporting
  • Trial-related materials documentation

Patient Information Leaflets

Clear, accessible translations of PILs that meet EMA template requirements while ensuring patient comprehension and regulatory compliance across Greek-speaking markets.

Labels & Packaging

Precise translation of pharmaceutical labels and packaging materials, maintaining regulatory compliance with MDR/IVDR requirements and ensuring accurate product information.

Safety Reports

Expert translation of pharmacovigilance documentation, including adverse event reports, periodic safety updates, and risk management plans with terminology consistency.

Professional translation of marketing materials, product launches, sales documentation, and promotional content pharmaceutical companies.

Professional translation of healthcare marketing materials, medical education content, and communication campaigns for pharmaceutical companies.

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