Medical translation is a highly regulated field that requires terminology precision, up-to-date technical knowledge, and familiarity with specific regulatory legislation, glossaries and instructions.
Paspartu' vast expertise -over 100.000 pages translated since 2006- in the medical & pharma field accounts for the prime position we occupy as prefered supplier of key international medical device producers, biotech and pharma companies.
Our medical translation team benefits from the involvement of regulatory professionals who are aware of specific country regulations and guidelines to be consulted when it comes to translating vital information, as well as of Subject Matter Experts employed in the revision phase of our Life Sciences documents.
Many companies operating in high-technology healthcare and related industries are run on a multinational basis, being significant exporters. Their regulatory affairs departments must be aware of the regulatory requirements in all the company’s export markets. Despite recent international efforts towards harmonisation of requirements, the regulations laid down by different governments and their interpretation by the regulatory agencies rarely match. The registration data prepared for one country frequently fail to meet the requirements for another. Paspartu has built a network of Regulatory professionals, whom with their detailed knowledge of frequently changing regulations and guidelines, are called in to advise our team on such matters.
- ISO certifications: EN ISO 9001:2008 and DIN EN 15038:2006-08 are a guarantee of high-quality standards applied throughout the translation process
- implementing good practice translation principles - ISPOR (international Society for Pharmacoeconomics and Outcomes Research) and QRD (Quality Review of Documents) templates as outlines by EMA
- compliance with the marketing authorisation procedures for pharmaceutical products as outlined by EMA (European Medicines Agency) such as stylistic guidelines, content standards (eg. headers, statements, terms), format and layout etc.
- a 4-phase Quality Assurance process for best quality results: forward translation, (back translation), revision, review & Quality Control
- language infrastructure to optimize terminology consistency - translation tools, memories and glossaries available online in our internal ERP platform
- terminologists and linguistic validation experts with a Life Sciences background: diligent screening of translators assigned to work on your projects (1 in 10 selection ratio)
- significant gains for your budget and time to market: efficient project management, smart use of technology, plus operations based in Greece allow us to offer excellent rates to our clients
Paspartu services that help your business grow global:
- translation, proofreading, back translation, harmonization of language versions, linguistic validation with targeted patient groups, localization, medical writing, interpreting, Quality Cross Check of running language projects, translation API for multilingual website management
We translate and localize for:
- Pharmaceutical Companies
- Biotechnology Companies
- Pharmaceutical Manufacturers
- Clinical Research Organizations (CRO)
- Original Equipment Manufacturers (OEM)
- Contract Manufacturing Oragnizations (CMO)
- Medical Devices Producers
- Healthcare units
- Laboratory units
At Paspartu we use back translation as a special quality control tool - for clinical trials documentation such as Patient Reported Outcomes, Informed Consent Forms, technical manuals and other highly sensitive documents where translation mistakes can cause major problems to the client, as important decisions regarding human health and safety are taken based on the translated texts.
Paspartu offers translation support in all stages of the Life Sciences Product cycle:
- Discovery / Research / Pre-clinical
- Testing & linguistic validation (cognitive debriefing) through patient interviews
- Sales and Marketing
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