Professional Medical Translation


Language Coverage

English, French, German, Spanish, Japanese, Korean and other languages

 

Translation Fields

Medical papers

Basic medicine: Biology, biochemistry, physiology, pathology, microbiology, immunology and statistics

Clinical medicine: Internal medicine, surgery, gynecology, obstetrics, pediatrics, hematology, nephrology, orthopedics, brain surgery and neurosciences

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Drug registration documents

Preclinical study: In vitro and in vivo study, such as general pharmacology, toxicology and cell toxicology

Clinical study: , , , phase clinical research documents, such as IB, study program, study report, ethics documents and safety report

Pharmaceutical research: Productive technology, prescription, stability, test method and impurity study

Certification documents: GLP, GCP, GMP, quality test report and license transfer

Medical devices registration documents

Instructions for use: Operator manual and operation guideline

Research documents: Performance test report, CE certification and ISO standard certification

Package information: Package instruction, label and marking

Test report: Quality test report and the report of quality sampling inspection for detection institution

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Laws and regulations

Industry research guideline: Industry research guideline released by FDA/EMA/CFDA

Fields research guideline: Fields research guideline released by FDA/EMA/CFDA

Supervision decree: Supervision decree and regulation released by FDA/EMA/CFDA

Other documents

Product brochure: Product promotion documents

Poster: Propaganda poster

 

Translation Team

All translators have master's degree or above and have a long-term fixed contract with us

Most of them are experts and scholars serving the fields including medical science, pharmacy and medical devices, mainly from universities, medical research institutions, pharmaceutical R&D institutions and clinical research centers

Most translators are returned experts or scholars who have studied in the U.S., Europe and Japan

They all are equipped with excellent bilingual translation capability, solid academic background of medicine and extensive professional experience in medical and pharmaceutical translation

All of the translators have an average of more than five years of professional experience in medical translation

 

Translation Resources

We own a complete terminology database and corpus for the fields including medical science, pharmacy, medical devices, law and finance

The self-developed Blue Jidian Online English-Chinese Medical Dictionary has been put into use

The self-developed Internet-based Medical Translation Project Management System has been put into use

We introduced the Chinese Pharmacopoeia, European Pharmacopoeia, United StatesPharmacopoeia and HPLC Atlas of Drugs in Chinese Pharmacopoeia (VERSION 2010)

We introduced ICH Technical Requirements for International Drug Registration (Safety, Clinic and Quality) and technical guidelines for drug R&D issued by FDA and EMA

We regularly participate in symposiums held by Center for Drug Evaluation (CDE), and Center for Drug Reevaluation (CDR), Chinese Pharmacopoeia Commission (CPC), Chinese Pharmaceutical Association (CPA), and National Institutes for Food and Drug Control (NIFDC)

We have successfully completed registration data translation of more than 60 imported drugs, with the pass rate of nearly 100%

We hire external experts of medical science and pharmacy and other fields as academic consultants to answer difficult academic problems and conduct translation quality assessment

 

Quality Control

We have developed Standardized Operation Procedures (SOP) for Translation Quality Management to ensure that the translation quality reaches the professional requirements of accurate, standardized and easy to understand

We first introduced and implemented GB/T19363.1-2008 and GB/T19682-2005, national translation quality standards for translation services, in China

 

Quality Assurance

Qualification authentication of translators: Translators, who pass the test for the level of translation and expertise, are grouped based on the professional background and then carry out the translation task

Operate the project in accordance with standardized operation procedures (SOP)

Quality standards: Casually inspect the quality in accordance with quality standard. Those who do not meet the standard are expected to redo the job until the standard is reached

 

Translation Speed

We guarantee to complete translation of 5,000-8,000 Chinese characters per day. 20% -30% surcharges are required for higher speed

The translation speed will slow down properly for documents related to laws, such as drug instructions, core data sheets of drugs, technical research guidelines, and laws and regulations

 

Time Control

Make translation plan: Make translation plan by project manager

Control time points: Control the translation process in accordance with the time points of translation plan

Control critical quality: Inspect casually the quality of translation or check and take the corresponding measures to ensure the quality meets the requirements of customers

 

Translation Format

We are able to conduct text composition, graphics processing and output settings, etc. for translation documents in accordance with specific technical requirements of clients

Registration documents of drugs or medical devices are processed in accordance with the Technical Requirements of Application Documents issued by CDE



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