Translation of Medical & Pharmaceutical Documents

Translation of Medical & Pharmaceutical Documents

Medical Translation-Translating medical & pharmaceutical documents. Paspartu, an 17100 ISO certified medical translation agency, delivers complete translation solutions for the medical and pharma industry, covering research, clinical trial, regulatory and pharmacovigilance documentation in 40 languages.

Medical translation requires a deep understanding of the specialized domain it refers to, of the specific regulatory guidelines of each region with respect to market entrance, and of the 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 1.000.000 pages for the medical industry alone, for key CROs, medical instruments & device producers, medical technology manufacturers, pharmaceutical companies, biotechnology, cosmetic, chemicals and other Life Sciences related clients in Europe, USA and Canada.

Our main focus in medical translations is on:

  • accuracy
  • thorough quality check for all languages and projects alike
  • glossary creation and management
  • file versions management
  • compliance with regulatory protocols
  • unique project/ account point of contact
  • confidentiality and security of information
  • client feedback implementation

Types of 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
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)

 

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

Our medical translation team is made of:

  • professional translators specialised in medical science

  • medical scientists

  • physicians

  • chemists

  • veterinarians

  • Life Science graduates

Skills and Qualifications of Paspartu Medical Translators:

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.