瑞欧佰药(杭州)医药科技有限公司
公司介绍

瑞欧佰药(杭州)医药科技有限公司,是杭州瑞欧科技有限公司的子公司。自2009年公司成立以来,瑞欧科技为各国政府、协会、社会团体提供技术支持,服务数千家企业,完成了数万个产品注册、登记和咨询项目,为消除贸易壁垒,促进全球贸易一体化提供了优质的技术服务。


瑞欧佰药是一家聚焦医药行业的技术服务公司,为企业提供专业的药品法规咨询和供应链服务,在中国、欧洲、美国、日本、韩国等地均有公司或办事处。公司团队中拥有多名资深药效学评估、药品研发和药事法规专家以及国际化商务团队,可以为全球客户提供药品制剂、药品原料、药用辅料和药包材的主流市场准入服务以及产品上市后的法规服务。瑞欧佰药还提供一站式的药品供应链服务,为保证药品的高品质,公司坚持海外生产厂家直供策略。随着国人对药品疗效要求不断提高,瑞欧佰药经营高品质进口药品的品牌优势更加凸显。


1、专注医药合规 共享健康生活

2、立足中国 运筹全球

3、让药品注册变得更简单

产品/服务
Product Registration
·Application for Clinical Approval: CTA, BLA, BE and MRCTs ·Application for Market Approval: NDA, ANDA ·DMF Filing for APIs, Pharmaceutical Excipients and Packaging Materials ·Supplementary Application/Re-registration
Registration Strategy
·Registration Feasibility Assessment ·Registration and Regulation Consultation ·Registration Pathway, Strategy and Risk Assessment
GMP Compliance
·GMP Compliance Consultancy to Meet Current China NMPA/FDA/EU/WHO Expectations ·Facility Design Reviews ·Validation Consultants ·Vendor Assurance/Supplier Audits
Customized Training
·Regulatory Affairs Guidance and Best Pathways to China ·Product Registration (NDAs, ANDAs & MA+MAH) ·Drugs Master File (DMF) Filing ·GMP Compliance and Certification ·Post-market Regulatory Supervision of Drugs
Local gency
·Registration Application & DMF Filing ·Regulatory Communication with Local Authorities ·Application of Change ·Compilation, Editing and Submission of Annual Reports
Translation Service
·Dossiers ·Pharmacology and Toxicology Reports ·Clinical Trials ·Labels, Package Insert and Journals
展台人员
Jack Hong
General Manager of BaiPharm
邮箱: info@baipharm.com
Tel: +(86) 571-87007555