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FDA/EMA Inspection Readiness:
Ensuring Compliance with Confidence
FDA/EMA检查准备：
确保合规无忧
Start Strong with the Quality Department
从质量部门开始稳步推进
Begins with the Quality Department taking the lead to initiate the Inspection Readiness strategy
从质量部门开始启动检查准备策略
Readiness Process Initiation: We can guide the Sponsor team through a robust readiness program to kickstart the preparations.
准备流程启动：我们引导申办方团队启动精实的准备计划以开展准备工作。
Develop Inspection Readiness Checklist: Develop a meticulous checklist to cover critical aspects such as GCP/GVP processes and documentation review.
制定检查准备清单：我们制定详细的清单，涵盖GCP/GVP流程、文档审阅等关键方面。
Inspection Readiness Process Rollout: Our team can help the Sponsor team roll out the readiness process across the organization.
检查准备流程实施：我们的团队会帮助申办方团队在组织内推广准备流程。
Comprehensive Training: We provide in-depth Inspection Readiness training and coaching to ensure all relevant departments understand their roles in the readiness process and facing the inspection.
详实的培训：我们提供深入的培训与指导，确保所有相关部门理解其在准备流程中的角色及检查应对。
Issue Management: We support the Sponsor team in addressing issues swiftly to reduce compliance risk.
问题管理：我们支持申办方团队解决问题以降低合规风险。
Sponsor Mock Inspection & cQMS assessment
申办方模拟检查与质量管理体系评估
We provide sponsor mock inspection services to evaluate the study management processes and clinical quality management system.
我们提供申办方模拟检查服务，以评估申办方临床试验管理流程及临床质量管理体系。
Interview & Document Review: We review processes within the Sponsor’s organization and interview the relevant functional team members to ensure compliance throughout the study such as the roles and responsibilities of the study management team and the interface with business partners.
面谈与文件审阅：我们审阅申办方组织内的流程及与相关团队成员面谈，以确保临床试验过程的合规，如研究管理团队的角色与职责及与业务合作伙伴的对接合规。
Pharmacovigilance and Safety Data Exchange (SDEA) Review: We assess pharmacovigilance systems and the adequacy of contracts, including Safety Data Exchange Agreements (SDEAs), to support post-marketing safety oversight in the U.S.
审阅SDEA(药物警戒和安全数据交换协议)：我们评估药物警戒系统和合同的充分性，包括安全数据交换协议，以支持在美国/欧盟的上市后安全监督。
Clinical QMS Assessment: We evaluate the implemented clinical Quality Management System (cQMS) for its completeness, effectiveness, and efficiency, ensuring it meets regulatory compliance and is prepared for an upcoming FDA inspection.
临床质量管理系统评估：评估已实施的临床质量管理系统(cQMS)的完整性和有效性，确保其符合即将到来的FDA/EMA检查监管要求。
cQMS Gap Analysis: Identify areas where the cQMS can be improved, including suggesting enhancements to current processes and developing new processes and quality documents.
临床质量管理系统缺口分析及优化：识别cQMS可以改进的地方，包括建议现有流程的改进以及开发新的流程和质量文件。
cQMS Optimization: Provide Sponsor with SOP templates to assist in refining existing business processes or establishing new ones, facilitating the development and implementation of these standard operating procedures.
优化临床质量管理系统：提供申办方新增或修订的SOP文件，以帮助改进现有业务流程或建立新的流程，促进这些标准操作程序的制定和实施。
Final Agenda & Reporting: A final agenda will be provided 14 days before the on-site assessment, and a detailed assessment report will be delivered within 30 days.
最终议程与报告：现场评估前14日内提交提供最终议程， 30日内提供评估报告。
Clinical Site/Vendor Mock Inspection & Training
研究中心/供应商模拟检查与培训
Interview & Document Review: We conduct a thorough review of the processes at clinical sites/vendors for study management. This includes identifying current issues and providing recommendations to ensure regulatory compliance.
面谈与文件审阅：我们审阅研究中心/供应商的研究管理流程，包括识别当前问题并提供解决建议，以确保符合法规要求。
Clinical Sites’ Inspection Readiness Training: We provide GCP inspection readiness training focused on managing compliance, deviations, CAPAs, and FDA/EMA inspection readiness.
研究中心检查准备培训：我们提供GCP检查准备培训，重点关注合规管理、偏差管理、CAPA以及FDA/EMA检查准备。
FDA/EMA Inspection On-site Support: We offer onsite support and provide recommendations for FDA/EMA inspection queries and responses.
FDA/EMA检查现场支持：我们提供FDA/EMA检查现场支持，并对检查员的质疑提出建议回复。
Why Choose Widler & Schiemann Ltd.
选择卫森医药咨询的原因
WS Consultants Expertise: Our consultants bring over 20 years of experience from leading pharmaceutical and facing regulatory inspections, we specialize in helping organizations navigate the complex FDA inspection process.
WS顾问的专业知识：我们的顾问拥有来自领先制药和应对监管检查超过20年的经验，我们专注于帮助企业应对复杂的FDA/EMA检查流程。
Our end-to-end services, from initial preparation to ongoing support, ensure that you are always inspection-ready.
我们的检查准备全过程顾问服务，从初期准备到持续支持，确保您始终准备就绪。
We provide long-term support, ensuring your inspection readiness process is always aligned with the latest industry standards and regulatory requirements.
我们提供长期支持，确保检查准备流程始终符合最新的行业标准和监管要求。
We look forward to working side by side with your team to deliver quality, compliance, and successful FDA/EMA inspection.
我们期待与您的团队并肩合作，达成质量合规，顺利完成FDA/EMA检查。
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