凯理斯顾问在监管运作和合规方面有近100年的累积经验,是处理全球监管问题的专家。
通过我们的团队帮助您优化监管流程,满足不断变化、对进行产品注册至关重要的要求,让世界各地的患者都能在市场上买到您的产品。
凯理斯顾问在监管运作和合规方面有近100年的累积经验,是处理全球监管问题的专家。
通过我们的团队帮助您优化监管流程,满足不断变化、对进行产品注册至关重要的要求,让世界各地的患者都能在市场上买到您的产品。
将凯理斯资深监管专家的深厚和多样的经验运用到您自己的监管团队。
Darren has 25 years in the pharmaceutical industry with experience, knowledge and expertise gained w...<i>了解更多信息</i>
Darren has 25 years in the pharmaceutical industry with experience, knowledge and expertise gained within Regulatory Information Management, Regulatory Affairs, Compliance and Quality Assurance. He currently provides regulatory and consulting services for the implementation and operational use of the Calyx Regulatory Information Management (RIM) system, specializing in EU procedures, XEVMPD, IDMP and Combination Products. Customer focused, Darren supports clients to optimise their use of the RIM system and provides “fit for purpose” solutions to the client’s constantly evolving requirements.
For more than 15 years, Stephan has managed numerous Regulatory Information Management (RIM) project...<i>了解更多信息</i>
For more than 15 years, Stephan has managed numerous Regulatory Information Management (RIM) projects and complex data migrations. With both technical and business expertise, he has assisted numerous clients with XEVMPD and IDMP implementations, also working with Calyx RIM Product Management as a subject matter expert.
As a RIM Product Owner, Julia works closely with Calyx’s Engineering and Regulatory Consultants te...<i>了解更多信息</i>
As a RIM Product Owner, Julia works closely with Calyx’s Engineering and Regulatory Consultants teams to implement IDMP features within Calyx RIM, leveraging her extensive Article 57 experience capturing data and managing XEVMPD submissions. Her expertise includes Registration Planning & Tracking and Product Detail Management, with a focus on XEVMPD and IDMP.
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