GMP certification translation
Time: 12:48:50, December 28, 2017
According to the deployment of the State Drug Administration, all pharmaceutical trading enterprises that have passed the certificate renewal this time should get GSP certification within 3-5 years. Those enterprises that fail to obtain GSP certification will be disqualified from dealing in drugs in the next round of license renewal. Therefore, the implementation of GSP will play an important role in changing the current situation of excessive drug distribution enterprises and disordered drug trade order, promoting drug distribution enterprises to improve their management level and promoting the economic structure adjustment of drug trade. The current GSP is a technical barrier for drug market access. Cro translation
refers to clinical research organization, which mainly includes the design and consultation of clinical trial scheme and case report form, clinical trial supervision, data management, statistical analysis and writing of statistical analysis report, etc., which is a kind of outsourcing service with high professional requirements. The target market is mainly focused on pharmaceutical companies doing medical statistics and clinical trials. GAP certification: production quality management standard of Chinese medicinal materials. It is determined to ensure the quality of Chinese medicinal materials. From the ecological environment, planting to cultivation, harvesting to transportation, packaging, every link should be under strict control. CTD data translation: in order to implement the legislative spirit of "imitation should be the same" in the "drug registration management measures", and promote China's generic drugs to enter the international market, the National Drug Evaluation Center has referred to the international common technical documents (common technical) Document (CTD for short), organized the drafting of CTD documents for domestic generic drug registration application, including the requirements for submission of CTD format application materials (Pharmaceutical part and bioequivalence part), and main research information summary table (Pharmaceutical part and bioequivalence part).
Shanghai inteprin translation company（ www.interpre.com.cn ）He has been engaged in the translation of pharmaceutical certification for many years, and he is a doctor of clinical medicine or a doctor of pharmacy and a university professor. Some of them focus on clinical medicine translation, some focus on pharmacy and biopharmaceutical translation, and some focus on the translation of medical papers. Senior reviewers shall be experts in the field of medicine or pharmacy or foreign experts. The preparation of manuscripts on drug registration is controlled by bilingual professionals with drug registration experience. They usually work in large foreign pharmaceutical enterprises such as Glaxo and Lilly for many years. The documents they write meet the approval of FDA, SFDA and other international and domestic drug and food administration. Our translation business covers the following areas:
Basic medical translation;
Physiology, pathology, human anatomy, biochemistry, molecular biology, cell biology, biomedical engineering, biological diagnosis technology, medical genetics, medical immunology, medical microbiology, preventive medicine, epidemiology, medical statistics, medical management, basic theory of traditional Chinese medicine, diagnosis of traditional Chinese medicine, TCM prescription, Chinese medicine, acupuncture and moxibustion, and medical psychology Science of science, medical philosophy, medical health care, etc.
Clinical medicine translation:
Cardiovascular medicine, neurology, respiratory medicine, Gastroenterology, Nephrology, oncology, general surgery, neurosurgery, Urology, brain surgery, vascular surgery, hematology, orthopedics, endocrinology, gynecology, andrology, pediatrics, dentistry, ophthalmology, ENT, anesthesiology, dermatology and Venereology, clinical epidemiology (DME), medical laboratory, internal medicine of traditional Chinese medicine TCM surgery, TCM Gynecology, rehabilitation medicine, sports medicine, etc.
Pharmacology, toxicology, pharmacognosy, pharmaceutical chemistry, pharmaceutical analysis, pharmaceutics, formulation and technology of preparations, sources and quality standards of raw materials and excipients, drug test reports, biopharmaceuticals, acute toxicity, chronic toxicity, skin irritation test, and reproduction ）Development and genotoxicity trials, phase I-IV clinical trials of new drugs (International multi center, double-blind, randomized controlled trials, etc.), application dossier for new drug registration, investigator's brochure and instruction for use Drug patents, drug research contracts, etc.
Translation of medical device (material) and product information and operation manual
IEC report (IEC Report, X-ray machine, ultrasound, MRI (nuclear magnetic resonance), CT (computed tomography), pet (positron emission computed tomography), SPECT (single photon emission computed tomography), DICOM (medical digital imaging and transmission), linear accelerator, pressure generator, ventilator, blood purifier, cardiac pacemaker, surgical instruments, dental medical equipment and other products And registration materials, radiation, nuclear medicine, laboratory and clinical diagnosis and testing equipment, including blood biochemical testing, ELISA (enzyme-linked immunosorbent assay) kit, PCR or RT-PCR, gene chip, protein chip technology, etc.
Interpretation of international conferences and business talks
On site interpretation and simultaneous interpretation of international academic conferences, seminars and annual conferences of various disciplines; production and translation of teleconference, teleconference, journals of international conferences of various disciplines, compilation of papers, production and translation of ppt documents, video and video materials, conference schedule and records translation, and general business conference interpretation, accompanying interpretation, etc.
Cosmetics and health products translation:
Product introductions and instructions of various cosmetics, skin care products and health care products, as well as product production technology, product registration information, etc., as well as medical fitness, medical cosmetology, etc.
Product introduction, instruction manual, food function test, domestic registration and product export information of various foods, drinks, medicated meals, etc.
Basic theory of veterinary medicine, clinical medicine, pet domestication, product information of veterinary medical equipment and equipment, and animal husbandry.
Translation and localization of magazines, journals and websites
The contents, titles, abstracts, keywords, full text of medical papers, medical information, news, reports, communications, etc. at home and abroad, as well as medical web pages, website translation, hospital information system (his), medical software localization, etc.