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Life Sciences Translation Services
We provide end-to-end language translation support for every phase of the medical products lifecycle - from pre-clinical to post-market.
For over 20 years, Yaxincheng has supported leading pharma, medical device, biotech companies, CROs and other medical organizations with high-quality medical translation services that comply with all local regulatory requirements, minimize risk, and help our clients deliver reliable medical products and services to patients worldwide.
Materials translated include clinical research and development, registration affairs, marketing campaign, management and training, as well as national and international policies, laws and regulations, standards and guidelines for medical devices and pharmaceuticals. Product category includes chemical drugs and biologics, medical devices, veterinary drugs, IVD products, health & nutrition products, and cosmetic products.
We provide translation in a wide range of language pairs, including Chinese, English, French, German, Japanese, Korean, Spanish and so on.
Area of Expertise
Medical Devices
All kinds of medical devices are covered.
Whole set of registration dossiers from Class I to Class III medical devices (risk analysis data, product technical requirements, test report, clinical documents, IFUs, labels, QMS documents related to product R&D and GMP, product safety and effectiveness supporting documents), basic research papers, articles and literature, and training and marketing materials
Human Drugs
Translation covers nearly every therapeutic areas regarding chemical drugs and biologics.
Registration dossiers (administrative documents, clinical summary and overview, CMC, non-clinical/clinical study), basic research papers, articles and literature, and training and marketing materials
In-vitro Diagnostics
Class I, II and III IVD products are covered, mainly including: microbiological culture media; reagents testing of protein, carbohydrate, drugs, drug metabolites, and autoantibodies; reagents for microorganism identification or drug susceptibility test; reagents for testing of pathogenic pathogen antigen, antibodies and nucleic acids, allergic reaction (allergen), etc.
Veterinary Drugs
Pharmacological and toxicological studies, clinical studies, residue studies, package insert, labels, etc.
Value-added Service
Pharmacovigilance and medical device vigilance services, eCTD/eRPS services, labor dispatch, graphic design/multi-media production, simultaneous/consecutive interpretation
Linguistic Validation
Inclusion of broader global patient population in a study will produce more realistic and objective study results, but may also pose new complex issues. With linguistic validation, Yaxincheng ensures the accuracy of the translated version of the Clinical Outcome Assessment (COA), delivering both linguistic and conceptual equivalence between the language pairs, so as to reduce the mistranslation-resulted risk in clinical trials.
Quality Management System
ISO 27001 certified in 2021
ISO 17100 certified in 2021
ISO 9001 certified since 2011
Became a unit member of Translators Association of China in 2020
Yaxincheng is one of the few medical translation companies in China certificated with both ISO 9001:2015 & ISO 17100:2015 and is a unit member of Translators Association of China. We take our disciplined adherence and commitment to these standards and more stringent internal SOPs because we understand our clients’ quality and regulatory environments.
Yaxincheng employs a 3-tier linguistic review process to ensure accurate medical translations. Besides, there are other means in place to further mitigate risk, monitor project, prevent errors before delivery, such as internal complaint mechanism, QC spot, translation quality scoring system, performance evaluation system and standardized customer complaint handling procedure.
As a unit member of Translators Association of China, we encourage our staff to actively interact with industry peers to share best practices, discover new tools, get education courses and training materials and resources to sharpen their skills and widen their vision in the field.
Continuous Innovation
To keep pace with changing technology, every year, Yaxincheng ramps up investment in research and development of new technologies that can be used to increase productivity, shorten delivery lead time, reduce error rate, and improve customer satisfaction.
An on-line translation project management system, combining with the processing and production data, the termbase and translation memories, the database of the client, internal and external resources, can provide a strong data support for resource allocation and process management throughout the production process.
We have developed a neural machine translation (NMT) system, which is a proprietary machine translation system rigorously trained using our over two decades of accumulated corpus of medical translations. With the combination of this system, an online real-time multi-user CAT technology, and human translation (HT) by professional medical translation experts, both the efficiency and proficiency can be fully achieved throughout the translation process.
Sticking to the innovation-driven development strategy, Yaxincheng has been awarded with National High-tech Enterprise Certificate since 2017.
