Life Sciences and Medical Translation Services in 40 languages

Life Sciences and Medical Translation Services

Life Sciences and Medical Translation- Over the past 16 years Paspartu has become one of Europe’s leading providers of Medical and Pharmaceutical translation. The company has been involved in major translation projects working alongside multinational pharmaceutical companies, CROs, medical device and technology manufacturers, and has aligned its processes and quality management systems to meet their demanding translation requirements.

PHARMA TRANSLATION SERVICES – for private pharma companies, CROs, and regulatory bodies (such as EMA, ECHA etc)

Paspartu assists Marketing Authorization Holders, medium-sized and major drug producers in Europe in translating their new pharma products into all European languages for marketing authorization purposes.

SmPC, labelling, and package leaflets are some of the main documents required by the EMA (European Medicines Agency) when a company applies for marketing authorization of a new medicine. The English translation of these documents is reviewed by the 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 documents commonly translated by Paspartu’s dedicated medical team, in the context of EMA related projects.

Are you preparing any drug products for the EMA centralized approval procedure? Let’s talk best translation tactics for SmPC, PIL and Labelling, for national, MR, DC or centralized procedures!

Paspartu offers Life Sciences and Medical Translation services in 40 languages for clinical studies, regulatory documentation etc, in the following medical fields:

Medical Translations
Biotechnology IVD, laboratory Pharmaceuticals Hospitals Clinical Research Healthcare Medical Devices Medical technology Connected/ digital healthcare

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.

At Paspartu we have worked extensively on translation projects for IVD, laboratory and microbiology leading companies in Europe, Canada, USA and Korea. This expertise makes Paspartu a true point of reference when top manufacturers in these fields chose their translation partner.

Types of pharmaceutical and medical documents we translate:

Research & Development	Regulatory Affairs
Patents Scientific articles Questionnaires Lab reports Tests Validation reports	Registration dossiers Labels and Package inserts Summary of Product Characteristics Adverse Event Report forms CMC documentation IND and NDA 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 Data sheets Deviation Reports Validation reports	Marketing collateral Websites and Portals Multimedia Promotional materials Patient Education (CMI and PHI) E-Learning documentation 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 our Medical Translators:

University Degree in Translation
Terminologists with a degree in Life Sciences/ medical/ pharma
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

Certificate of Translation Accuracy offered free of charge

Most medical and pharma companies require that all medical translations are certified by medically trained translators before submitting the translated documentation to their regulatory bodies (IRB, the FDA, the EMA, etc.). Paspartu offers these Certificates free of charge.

Below is a useful link to read about how the new MDR regulation affects Class I medical device producers, which in most cases are exempted from going through a regulatory approval process.

https://www.linkedin.com/posts/diana-anca-1101a9123_classi-medicalabrdevice-mdr-activity-6872115035389403136-VmDQ?utm_source=linkedin_share&utm_medium=member_desktop_web

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

Check our translation projects with key medical technology, pharma and Life Sciences companies here:

https://www.paspartutranslations.com/life-science-medical-and-pharma-translation/