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  • Marty | Widler & Schiemann

    马丁·E·祖祖洛 美洲董事总经理 关闭 拥有 30 多年生命科学研发/制造经验 拥有 5 年以上 Biogen 行业经验(制造、技术转让、工艺开发和质量) 拥有 25 年以上技术和管理咨询经验(普华永道、德勤、埃森哲、IBM、Parexel) ​ 特产 质量风险管理 工艺设计与优化 监管信息管理 组织发展 欧盟药品法规/欧盟IVDR SOP系统和工艺流程 技术转移操作 经验 监管信息管理项目负责人 – 目前领导一家领先的脑健康公司的监管信息管理 (RIM) 系统的监管事务计划规划能力建设。目标是开发具体的项目规划方法、方法和工件来管理整个 RIM 项目,并为公司的转型办公室职能开发可扩展的资产。最终成功上线。 市场授权和变更控制合规性 – 为多个领域的多个客户领导审计和评估项目,解决变更控制、注册管理、标签和 CAPA 的合规性以及设备和专业制药的不合规问题。 监管事务组织蓝图 – 领导一家领先专业提供商的监管事务组织的蓝图设计工作,从而提高了监管运营资源和结构的有效性。 临床流程转型 – 领导一个横跨三个部门的大型全球团队,为一家顶级制药公司实施一项耗资数百万美元的多年转型计划。这项复杂的参与涉及项目规划和对八个工作流程的支持,这些工作流程解决了当前和未来的状态流程和技术要求。 医疗器械“内部”CRO 评估 – 领导最近采用此模式的最大医疗器械制造商的内部集中式 CRO 组织的流程、技术和供应商能力以及绩效评估。 cGMP 风险评估 – 对多家制药和医疗器械制造商的回顾性验证数据进行了大量 cGMP 风险评估。进行全面的设施审查和审计计划,以纳入公司的 ELA/PLA 提交中。为多家公司协调现场SOP和技术转让操作培训计划。 同意令计划管理 – 为一家根据同意令运营的大型多元化生物制药公司协调关键道德和消费品的多年批次记录审查。与生产、质量控制和人力资源团队进行广泛的交流,并担任客户和公司之间的 cGMP 合规资源。

  • Other Services | Widler & Schiemann

    其他服务 Other Services 尽职调查支持 多系统支持 与我们的合作伙伴合作,WSQMS 可以为您提供经过验证、适合用途的基于云的 e QMS 和 eTMF 解决方案 选择合适的系统 支持系统的实施和验证 系统业务管理员管理​ 可定制的支持 请联系我们 如果你 需要根据您公司的规格量身定制的支持,包括但不限于: 组织设计支持 确定其他地点的合作伙伴 回到顶部 威德勒席曼尽职调查咨询通过评估影响患者安全和医疗保健的风险提供专业知识。数据完整性、质量和风险管理和产品及服务过程质量

  • Copy of Drug Development Consultancy ... | Widler & Schiemann

    Drug Development Consultancy & Support Widler & Schiemann's experienced subject matter experts can support you in drug development activities by providing customized strategic advisory and coaching services to your organization or by acting as a member of your team providing hands-on expertise on key deliverables. Drug Development Stategy Back to Top Drug Development and Regulatory Strategy ​ The combined knowledge across WSQMS areas of expertise can be utilized to support: Target Product Profile Developm ent and Review Product and Clinical Development Plans Regulatory Affairs Services ​ WSQMS global regulatory experts have 15-25 years' experience across the US, China and Europe, providing support with: Regulatory intelligence and expert advice on local regulatory requirements and procedures (US, EU, China) Advice and execution of overall regulatory strategy and submission strategy (local or global strategies) Health Authority interactions and Regulatory Representative (China, US and EU, Switzerland, UK, APAC) Licensing, registration and maintenance (DMF, IND, CTA, NDA, ANDA, BLA submissions in China, US, EU et al) Post-market activities Regulatory operation excellence model design and implementation GDPR representation for non-EU-based companies Back to Top IMP Management Support ​ With our experts in Investigational Medicinal Products (IMP) management, we can support your organization remotely and hands-on with the coordination and project management of: DP Manufacturing, packaging and labelling Overall supply chain logistics Inter-vendor communication and oversight Set-up of user requirement specifications for MES and IRT systems and conduction of related ‚User Acceptance Tests’ Dedicated In-house training courses for all staff involved in IMP Supply Chain Management Auditing of CMOs and logistic vendors Overall: business process re-engineering, CMO selection and oversight Clinical Operations Support ​ WSQMS can provide consultancy on most clinical operations activities: Project risk management TMF se t-up and management Trial management Vendor evaluation, selection and qualification Vendor Oversight Plan development Patient recruitment tactics

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