Medical Translation

Over the past nine years Paspartu has become one of Europe's leading providers of Pharmaceutical and Medical translation.The company has been involved in major translation projects working alongside multinational pharmaceutical companies, CROs, medical device manufacturers, and has designed and aligned its processes and quality management systems to meet their demanding translation requirements.

Paspartu has assisted Marketing Authorisation Holders in translating their new pharma products into all European languages. 

SmPC, labelling, and package leaflets are some of the main documents required by EMA (European Medicines Agency) when a company applies for marketing authorisation of a new medicine. The English translation of these documents is reviewed by EMA in the so-called pre-opinion phase. Drugs approval/ rejection decisions, recommendations for use, standard operating procedures as well as various scientific reports are other types of commonly translated documents by Paspartu medical team, in the context of EMA related projects (over 15.000 pages so far and counting).

Paspartu offers medical translation services in the following highly specialized areas:

Medical Translations
  • Biotechnology
  • Pharmaceuticals
  • Hospitals
  • Clinical Research
  • Healthcare
  • Medical Devices

Paspartu translators are experts in the pharmaceutical and medical fields and are categorized internally based on their knowledge and expertise of individual medical branches: such as pharmaceutics, human medicine, veterinary medicine, dentistry, healthcare, medical technology or medical research. Our language experts are familiar with industry guidelines and regulations, have access to pharmaceutical dictionaries and self-created industry databases and are fully aware of the key terminology and abbreviations in place, to give you the quality translations required to succeed in this competitive global market.

Types of pharmaceutical and medical documents we translate:

Research & DevelopmentRegulatory Affairs
  • Patents
  • Scientific articles
  • Questionnaires
  • Lab reports
  • Tests
  • Validation reports
  • Registration dossiers
  • Labels and Package inserts
  • Adverse Event Report forms
  • CMC documentation
  • IND and NDA documentation
  • Audit support
  • Instructions for Use (IFU) inserts
  • Declaration of Conformity
ManufacturingSales & Marketing
  • GMP documentation
  • Standard Operating Procedures (SOPs)
  • Batch records and MBRs
  • QMS audit documentation
  • 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)

Skills and Qualifications of Paspartu Medical Translators:

  • University Degree in Translation
  • Terminologists with a degree in Life Sciences
  • minimum 3 years translation experience and/or extensive training and knowledge of specific medical domains
  • Experience of the medical field in the required target and source language
  • Native understanding and local knowledge of the target language
  • The ability to write well in the target language
  • familiarity with regulatory requirements and guidelines issued by various regulatory bodies with respect to the multilingual translation of medical and pharmaceutical documentation

Certification of Translation Accuracy

Most countries require that all medical translations are certified by medically trained translators before submitted to their regulatory bodies such as: IRB, the FDA, the EMA, etc. Please contact your Account Manager should you require a Certificate of Translation Accuracy.

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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