- 一个 欧盟地址 must be provided for the Marketing Authorisation Holder (MAH), MIA, WDL and warehousing.
- 一种 药物警戒(PV) contact must also be provided for adverse event reporting. PV providers must all be in receipt of cGPV authorisation from an EU BOH. WBR work with EU and UK based partners to provide all PV requirements.
- 实验室测试服务 must also be engaged to ensure full release testing is provided including batch release and identity testing, product quality specification (PQS), stability, and storage indication testing.
所有实验室测试设施都必须持有CGMP认证。WBR与专业测试公司建立了合作合作伙伴关系,他们可以为释放制药产品提供所有测试要求。WBR QP被列入客户许可证,以审查批处理记录并代表其发布产品。
WBR持有MIA和WDL,并已由英国MHRA审核,并获得了CGMP认证的进口,仓储和分销服务。
WBR与非欧盟制造商合作,帮助他们将产品进口到欧洲,同时产生最低成本,因为他们可以在英国使用我们的设施和资源在建立自己的设施之前开始在欧洲进口和销售产品。