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Our Services 我们的服务 Widler & 遍布全球。 Schiemann 专注于提供为客户量身定制的产品开发解决方案和策略。我们与生物制药、医疗器械和药物开发等领域的客户合作。交付领域，利用我们在质量管理、药物开发咨询和支持方面的广泛集体经验，产生涵盖项目整个生命周期的持久成果，创建定制解决方案。 质量管理解决方案 药物开发 & 咨询支持 其他服务

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张淼 副合伙人，中国 关闭 4 年第三方审核员 在安斯泰来担任 2 年 QA 中国区负责人 KUNTUO（昆泰公司）3年培训/SOP管理/质量控制 在 L-Wyeth/Pfizer 从事 SCRA/PM 3 年 ·3年CRO监控 特产 GCP 审核与认证问题管理 检查准备情况和自检 GCP 培训：GCP/ICH-GCP、QA/QC、检查/审核准备、项目管理、现场监控、现场管理 SOP开发与管理 经验 执行与全球和地区相关的 GCP 审核本地，I-IV 期，肿瘤学和非肿瘤学研究 接受PMDA和CDI检查 截至2020年底，参与17家药企现场检查准备工作，默克、安斯泰来、信达生物、君实、基石药业、再鼎医药等6个产品已上市/顺利通过现场检查 为GCP审核员提供在职培训 提供与监控技能（21天）、现场管理（CRC）、检查准备、审核准备、项目管理相关的GCP培训 创建并管理KUNTUO（昆泰公司）的培训系统 开发、审查和管理临床质量体系

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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