药品申报部

MBM services single regulatorypractice

MBM 的药品申报部能够就与药物、天然保健品、医疗器械/诊断、食品和化妆品相关的众多法规问题为客户提供咨询。该小组由多学科律师组成,他们曾在加拿大卫生部工作,从事食品和药品法及相关法规的实施和执法,或者曾在大型制药公司工作:

我们的专业技能包括但不限于以下方面

各种法规制度下的产品分类;

法规审批过程中的操作包括向监管机构预提交和提交材料的活动,对于提交材料所获裁决的上诉;

专利药品合规性声明条例下的专利名单以及数据保护资格/排他性;

专利药品价格审查委员会申请以及处方清单和赔偿

如果您有任何问题需要我们的监管实践小组提供帮助请联系Susan Chao

 

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About MBM

 The process of invention is complete only with the IP protection provided in law. That's where MBM comes in. We match our clients' creative thinking with the creative protection needed to achieve their goals.Read More About MBM

Clarifications to the Data Protection Guidance Document

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