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Marco Theobold

Director of Medical Device and Drug Services

Registrar Corp Industry Expert

Since joining Registrar Corp in 2009, Mr. Theobald supervises a department of 20 regulatory specialists providing FDA regulatory services for pharmaceuticals, medical devices, radiation emitting devices and cosmetics. Over the years, he has represented Registrar Corp several times at trade shows and conferences, including MEDICA, FIME, and the UDI Conference as well as presented multiple webinars on medical device and cosmetic requirements, which were attended by businesses around the globe.

Background

Mr. Theobald was born in Germany and holds a Ph. D. from the University of Giessen/Germany in Biology/Genetics. He has more than twenty years of experience in Regulatory Consulting, Technical Services, Customer Service, and Team Leading.

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探索 I 类医疗器械、II 类和 III 类医疗器械之间的关键区别,同时了解其特征和监管细微差别。

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了解 FDA 许可和 FDA 批准之间的区别,以及它们如何适用于医疗器械和药物。

如何向中国监管机构提交您的主文件

通过提交 DMF 在全球范围内保护您的专有药物数据。信任 Registrar Corp 为满足 CDE、NMPA 要求提供专家协助。

向加拿大卫生部提交主文件

轻松浏览 DMF Health Canada 提交的内容。Registrar Corp 确保您的机密数据得到安全处理和合规。

向美国 FDA 提交您的药物主文件

通过向 FDA 提交药物主文件来保护您的专有数据。信任 Registrar Corp 提供专家协助和保密。

向欧盟的欧洲药品机构提交主文件

轻松浏览欧洲药品管理局提交流程。信任 Registrar Corp,以保护您的机密数据并确保符合 ASMF 要求。


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