Life Sciences and Medical Translation

Life Sciences and Medical Translation- Over the past nine 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 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 & Development	Regulatory 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

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 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
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 medical and pharma companies 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.

For any translation requests in the medical/ pharma field, please do not hesitate to contact our dedicated Life Sciences department at [email protected] or [email protected].