翻译领域:
 药品(包括疫苗)和医疗器械的注册资料:行政文件,药学研究资料(例如:原料药和制剂的质量标准、生产工艺及验证、分析方法及验证、稳定性资料等),药理毒理研究资料,临床研究资料(例如:临床试验方案、研究者手册、临床研究报告、统计分析计划、知情同意书),药品说明书,定期安全性更新报告(PSUR)等。
 体外诊断产品:诊断试剂和血液分析仪等
 化妆品和保健食品
 注册相关法规、技术指导原则、新闻稿、培训资料、法律合同等

注册代理:
 由资深注册专员为制药企业提供注册代理和注册咨询服务。


Translation:
Registration dossiers of drug (including vaccine) and medical device: administrative documents, pharmaceutical research data (e.g. Specification, manufacturing process and validation, analytical procedure and validation, and stability data of drug substances and drug products, etc.), pharmacology and toxicology studies, clinical study data (e.g. protocol, Investigator’s Brochure, Clinical Study Report and Statistical Analysis Plan, ICF), Package Insert, Periodic Safety Update Report (PSUR), etc.
In vitro diagnostic products: diagnostic reagents and blood analyzer, etc
Cosmetics and Health food
Laws and regulations, technical guidelines, press releases, training materials, contracts, etc
Registration agency:
Provide registration agency and consulting services by senior specialist

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