Product Description

Willingjet provides premium translation services for medical documents, biotech, and medical device companies, life sciences services companies and desktop publishing services 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 letter certified translation and medical device documentation 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

 

Professional DTP

We have self-developed DTP design service 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 for any language product.

 

Life Science Translation Services

Clinical Trial Translation

 

Regulatory Compliance Services

 

eCTD Filing

 

Medical Localization

 

Medical Interpretation

 

Medical Device

 

Advantages ADVANTAGES

21 Years of Experience

As a translation service company, Willingjet has over two decades of experience providing translation services to life science industry. Our team of professional linguists and experts has a deep understanding of the regulatory requirements, technical terminology, and cultural nuances necessary for successful translation of medical terminology.

 

Quality-Oriented

We are committed to delivering high-quality translations that meet the highest standards of accuracy, cultural appropriateness, and regulatory compliance. Our ISO 9001, ISO 17100 and ISO 13485 certifications demonstrate our commitment to quality management and continuous improvement.

 

Professional Team

Our team consists of highly qualified linguists and subject matter experts. All of our translators are native speakers of the target language and have a deep understanding of the cultural and linguistic nuances required for successful medical translations.

 

Always On-Time

We understand that deadlines are critical in any industry, which is why we prioritize on-time delivery. Our efficient project management processes, coupled with our experienced team, ensures that we deliver translations on time, every time.

 

Data Security

At Willingjet, we take data security very seriously. We use the latest encryption and security protocols to protect our clients' confidential information, and we have strict internal policies and procedures in place to ensure that all data is handled with the utmost care and confidentiality.

 

Cost-Competitive

We understand that cost is an important factor today, which is why we offer cost-competitive translation solutions without compromising on quality. We work with our clients to develop customized solutions that meet their budget and timeline requirements.