Life Science Solutions

TRANSLATION OF MEDICAL DOCUMENTS

Life Science Translation

Willingjet provides premium translation services for pharmaceutical, biotech, and medical device companies and CROs with high-quality.  

 

We have provided language solutions to the life science industry for more than two decades, our professional experts and native-speaking translators have more than ten years of experience, covering more than 100 languages. Willingjet has aquired ISO 17100 , ISO 9001:2015 and ISO 13485:2016 certifications to guarantee our medical translation services complying with the stringent regulatory requirements worldwide.

 

Medical translation document types

Documents included in drug registration dossier:

M2: Quality summary, non-clinical review and summary, clinical review and summary, etc.;

 

M3: Manufacturing information, specification, analytical methods and validation, stability study, container closure system for drug substance and drug product;

 

M4: Pharmacology, pharmocodynamic, pharmacokinetic, toxicology research reports, etc.;

 

M5: Clinical study protocol, clinical study report, investigator brochure, ccds, package insert, etc.

 

Documents from the medical device company:

Patient Information

 

Patient Reported Outcomes (PROs)

 

Medical device safety and pharmacovigilance document

 

Clinical trial protocol

 

Product labeling and packaging

 

Documents submitted to regulatory agencies

 

Instructions for use

 

Technical manual

 

Medical literature

 

Medical equipment instructions and installation manuals

 

Marketing and advertising

 

Websites, software, mobile apps and IoT

 

Online learning and training

 

Legal, financial documents

 

Documents from the medical device company:

Documents from CROs:

Managing Multi-regional clinical trial in many languages

 

Clinical trial documents

 

Patient engagement and recruitment

 

Contracts and POs

 

Registration dossier

 

Contact Us

Professional DTP

We have self-developed DTP software and are good at using industry-standard desktop typesetting and editing tools, including the eCTD format of drug/medical device registration dossier, user manuals, technical documents, and software GUI layout. Our DTP experts have professional knowledge of specific language environments and can produce high-standard dtp design service for any language product.

 https://www.willingjet.com/life-science-translation-solutions/