Medical & Pharmaceutical documents

Medical translation requires an understanding of the specialized domain it refers to, the specific regulatory guidelines of each region with respect to market entrance, as well as guidelines applying to translating medical documents as outlined by EMA (European Medicines Agency), FDA, ISPOR (International Society for Pharmacoeconomics and Outcomes Research) or other similar scientific and regulatory bodies.

Up to date, Paspartu has translated over 100.000 pages for the medical industry alone, for key CROs, medical instruments, devices & technology producers, pharmaceutical companies, biotechnology, cosmetic and other Life Sciences related clients.

Types of pharmaceutical and medical documents we translate:

 

Research & Development Regulatory Affairs
  • Patents
  • Scientific articles
  • Questionnaires
  • Lab reports
  • Tests
  • Validation reports
  • Registration dossiers
  • Centralised Procedure (CP)
  • Descentralised Procedure (DCP)
  • Mutual Recognition procedure (MRP)
  • Referral Procedure
  • Labels and Package inserts
  • Adverse Event Report forms
  • CMC documentation
  • NDA (New Drug Application) documentation
  • Audit support
  • Instructions for Use (IFU) inserts
  • Declaration of Conformity

Manufacturing Sales & Marketing
  • GMP documentation
  • Standard Operating Procedures (SOPs)
  • Batch records and MBRs
  • QMS audit documentation
  • (material safety) data sheets
  • Deviation Reports
  • Validation reports
  • Marketing collateral
  • Websites and Portals
  • Multimedia
  • Promotional materials
  • Patient Education (CMI and PHI)
  • E-Learning and training

Clinical Research
  • Clinical Trial Agreements (CTAs)
  • Investigator brochures
  • Adverse Event Reports (SAEs)
  • Patient Questionnaires
  • Case Report Forms (CRFs)
  • Institutional Contracts
  • Study Protocols and Synopses
  • IVRS prompts
  • Site Operations Manuals
  • Informed Consent Forms (ICFs)
  • Patient Diaries
  • Patient recruitment materials
  • EDC Documentation
  • Patient Reported Outcomes (PROs)

Our medical translation team is made of:
  • professional translators specialised in medical sciences
  • medical scientists
  • physicians
  • chemists
  • veterinarians
  • Life Sciences graduates
Skills and Qualifications of Paspartu Medical Translators:

  • University Degree in Translation Studies or Life Sciences
  • extensive training in/ knowledge of specific sub-medical domains
  • verifiable min.3 years experience of the medical field, in the required target and source language
  • translation checked by a second native speaker Subject Matter Specialist, with a degree in Life Sciences and experience in the project specialism
  • native understanding and local knowledge of the target language
  • the ability to write well in the target language
  • medical writing skills
  • linguistic validation skills through debriefing interviews on specific patient groups

For any translation requests in the medical/ pharma field, please do not hesitate to contact our dedicated Life Sciences department at 
diana@paspartu.gr or info@paspartu.gr.
 

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