We will conduct risk analysis on every element, beginning with the supply chain management system, through production and process control stages, to post-marketing customer services, ensuring sustainability via an effective CAPA management system and minimizing the possibilities of product recalls.

专家分析

从供应链管理系统到生产和过程控制阶段,再到售后客户服务,我们将对每个要素进行风险分析,通过有效的纠正措施和预防措施,管理系统然后能够确保可持续性,并最大程度地减少产品召回的可能性。

專家分析

從供應鏈管理系統到生產和過程控制階段,再到售後客戶服務,我們將對每個要素進行風險分析,通過有效的糾正措施和預防措施,管理系統然後能夠確保可持續性,並最大程度地減少產品召回的可能性。

industrIAL best practices

Good quality needs good open-mind vision, and we can provide the 3rd party opinion, develop a guidance along with the out-of-the-box thinking, so that your product can get approval, and be certified by the regulator from audit, and have a successful launch to fulfill marketing expectation.

策略计划

优质的产品需要良好的胸怀,我们可以提供第三者意见,与开箱即用的思维一起制定指导,以便您的产品获得批准,并由监管机构通过审核,并成功启动以达到市场期望。

策略計劃

優質的產品需要良好的胸懷,我們可以提供第三者意見,與開箱即用的思維一起制定指導,以便您的產品獲得批准,並由監管機構通過審核,並成功啟動以達到市場期望。

Our Services

strategic planning

risk ASSESSment

QUALITY & RISK MANAGEMENT COMPLIANCE Consulting

GMPSIGMA

expert analysis

STRATEGY & SUCCESS

Our experience with medical device and pharmaceutical CGMP, Environmental Management System, Occupational Health and Safety Laws, Product Safety & Reliability Testing requirements can help to resolve most of the regulatory compliance situation, from 483 to consent decree.

工业最佳实践

我们在医疗器械和药品的当前良好生产规范,环境管理系统,职业健康与安全法,产品安全与可靠性测试要求方面的经验,可以帮助解决大多数法规合规性问题。从483违规通知到法院下令的同意令。

工業最佳實踐

我們在醫療器械和藥品的當前良好生產規範,環境管理系統,職業健康與安全法,產品安全與可靠性測試要求方面的經驗,可以幫助解決大多數法規合規性問題。從483違規通知到法院下令的同意令。

If you are the manufacturer for regulated products, the QMS should be managed under an intensive on-going risk evaluation system. We can identify any SWOT in the process, to make sure that your products are fully complied with all-points risk analysis and control requirements.

风险评估

如果您是受管制产品的制造商,则应在密集的持续风险评估系统下处理质量管理体系。我们可以识别流程中的任何优势,劣势,机会和威胁,以确保您的产品完全符合所有方面的风险分析和控制要求。

風險評估

如果您是受管制產品的製造商,則應在密集的持續風險評估系統下處理質量管理體系。我們可以識別流程中的任何優勢,劣勢,機會和威脅,以確保您的產品完全符合所有方面的風險分析和控制要求。

In the regulated industry, the rendezvous point is where Quality Circle meets with Safety Way and Regulatory Boulevard. A strategic action plan follow with effective execution is always necessary to achieve compliant and market success.

在受监管的行业中,集合点是质量圈和安全方式与规章制度的交汇处。为了实现合规性和市场成功,始终必须执行有效的战略行动计划。

在受監管的行業中,集合點是質量圈和安全方式與規章制度的交匯處。為了實現合規性和市場成功,始終必須執行有效的戰略行動計劃。