Life Science Translation Services, Life Science Translation Company

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Life Science Translation

Medical translation document types

Medical Writing

End-to-End Project Management

Language Asset Management

Preparing Compliant eCTD Submissions

eCTD Services

CTD Triangle

Benefits

Drug Registration Services

Drug Registration Process

Key Benefits

Willingjet Linguistic Validation includes

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 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 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.

Content Creation and Management

Medical Writing

We offer medical writing solutions for pharmaceutical clients in need, specializing in writing summary documents in registration dossier, severe adverse reaction reports, medical-related monographs or papers that comply with ICH requirements. Our experienced registration experts first analyze client needs and assemble a writing team based on specific project requirements. Our registration experts track the entire writing process, while our seasoned writers perform quality control and review, ultimately delivering high-quality medical writing drafts.

Typical documents

Phase I-IV clincial study protocols for new drugs;

Other clinical study documents (investigator brochures, informed consent forms, case report forms);

Clinical study reports;

CMC part of registration dossier (Summary, specification, summary tables);

Search on clinical study-related literature;

Registration Dossier Writing: Common Technical Document (CTD) preparation, Module 1 preparation, Module 2-5 drafting, Quality overall summary (QOS) preparation, Electronic common technical document (eCTD) preparation.

End-to-End Project Management

Our project management team has a proven track record of delivering high-quality projects on time and within budget. We offer end-to-end project management services.

We have a large and professional translation project management team, and project managers with proficient and professional project management skills serve as the exclusive contacts of customers, manage all translation projects throughout the process, optimize massive translation work, and ensure all the translation process controlled, and delivery on time.

Project planning

Budget management

Resource allocation

Risk management

Quality control

Language Asset Management

Language assets refer to everything related to a language that is handled during translation and localization, including language style guides, glossaries, translation memories, and others. We help clients manage their language assets and provide enterprises with applicable language asset management solutions.

Translation Memory Management

Terminology Management

Translation Language Style Guide

Other Language Specific Assets

eCTD Submission

Preparing Compliant eCTD Submissions

Our eCTD submission service provides a comprehensive solution for establishing, reviewing, verifying, and publishing eCTD electronic submissions. Our expert eCTD technical team is equipped with a full lifecycle management eCTD electronic submission system, which includes document management and archive retrieval functions. We ensure that our service fully complies with ICH and regional guidelines, meeting the eCTD submission requirements of multiple countries, products, regions, and users.

eCTD Services

Authoritative and real-time eCTD regulatory interpretation and submission consulting services, assisting customers in establishing and improving eCTD submission management capabilities.

eCTD Format Layout

Adjust and standardize document formats such as Word/PDF based on eCTD electronic document requirements in different regions to meet submission requirements.

eCTD Electronic Submission Full Process Service

Full lifecycle management submission service covers the entire drug lifecycle. After completing the eCTD document preparation, generation, verification and publishing work, we can also undertake subsequent change, supplement, re-registration, and other lifecycle management services.

CTD Triangle

Benefits

Real-time

Compliance

Comprehansive

Customized

Drug Registration Services

We understand the complexities of the drug registration process and the importance of getting your products to market quickly and efficiently. Our team is dedicated to provide the highest quality drug registration services to meet your specific needs and regulatory requirements. We provide consultation, regulatory research, document selection and preparation, translation, DTP, intepretation and other necessary services during the whole process.

Drug registration

IND, NDA, ANDA, DMF filling, Drug Substances, Excipients, Drug Packing Materials filing, BE filling in China, USA and Europe.

Drug Registration Process

Initial Consultation

We will consult with you to determine your specific needs and requirements for drug registration in your target markets.

Regulatory Research

Our team of experts will conduct a comprehensive regulatory research to identify the regulatory requirements for drug registration in your target markets. Analyze the feasibility of drug registration in China, and provide a document list of application materials.

Gap Analysis

We will perform a gap analysis to identify any gaps in your existing data and documents that need to be addressed before submission to regulatory agencies. Help clients determine the final list of documents to be adopted, and guide applicants to prepare necessary technical documents and supporting documents.

Document Preparation

Our team will prepare all the required documents for submission to regulatory agencies, including review, translation, compilation of a package of registration dossier in the Common Technical Document (CTD) format.

eCTD Publishing

We will publish the electronic Common Technical Document (eCTD) for submission to regulatory agencies.

Submission

We will submit the eCTD to the regulatory agencies, on behalf of your compoany, as well as specification verification sample delivery, tracking and problem solving.

Review

We will monitor the progress of the submission and provide support for any inquiries or requests, consultation with regulatory agency and manufacturer, respond to inquiries from drug administration departments on behalf of clients to ensure the smooth completion of registration projects.

Approval

Once the regulatory agency approves your drug registration, we will provide ongoing support for maintenance and updates to keep your registration in compliance with regulatory requirements.

Linguistic Validation

Linguistic validation is a process of ensuring that medical translations accurately convey the intended meaning of the original text and are appropriate for the target audience. This involves assessing the linguistic and cultural equivalence of the translated material to ensure that it is culturally appropriate, easy to understand, and free of errors.

Key Benefits

Ensures that translated medical documents are accurate and appropriate for the target audience.

Minimizes the risk of misunderstandings, errors, and miscommunications.

Helps ensure regulatory compliance by meeting the requirements of regulatory agencies for translated materials.

Willingjet Linguistic Validation includes

Review and editing of translations by native speakers of the target language to ensure accuracy and cultural appropriateness.

Cognitive debriefing with target-language speakers to assess their comprehension and understanding of the translated material.

Back-translation to ensure that the translated material accurately reflects the meaning of the original text.

Double forward translation to minimize the misunderstand on source content or misalignment.

Cross-cultural adaptation to ensure that the translated material is culturally appropriate and relevant for the target audience.

Consulting on best practices for linguistic validation and regulatory compliance.

Life Science Translation Services

Clinical Trial Translation

Regulatory Compliance Services

eCTD Filing

Medical Localization

Medical Interpretation

Medical Device

Advantages

21 Years of Experience

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 medical translations.

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.

How can we help you?

Our Service

Willingjet's Information

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HEADQUARTERS

Willingjet Life Science Ltd.
Room 508, Unit 1, No.2 F Building, Greenland Central Plaza, Leyuan Road, Daxing District, Beijing 102627, China.
Office Phone: +86 10 8022 3713

+86 10 8022 3713

Life Science Translation Solutions

Translation of Medical Documents

Content Creation and Management

eCTD Submission

Drug Registration Services

Linguistic Validation