Corgenix产品代理
Corgenix产品代理
对于合约开发，让我们与众不同的是我们是平台不可知论者。这意味着我们将根据客户的要求在任何平台上开发测试。我们将在满足您客户的技术、临床和商业要求的任何平台上进行开发。此外，我们以我们的项目管理技能和强大的质量管理体系为荣。我们所有的开发项目都在严格的设计控制下进行，重点是满足承诺的时间表和预算。我们还帮助我们的合作伙伴进行 FDA 和国际注册流程以及商业化。此外，我们还提供检测验证服务、重现性和桥接研究。
对于合同制造，质量是关键的差异化因素。我们是 ISO-13485:2016，一家 FDA 注册工厂，符合 GMP 标准。我们在布鲁姆菲尔德工厂生产自有品牌测试以及我们自己的产品线。
Corgenix 还拥有一个现场 CAP/CLIA 认证实验室。无论您需要研究或临床试验测试的支持，还是常规临床测试服务，我们都可以为您提供帮助。
orgenix, founded in 1990, is medical diagnostics company based in Broomfield, Colorado. We are a full service partner to the Diagnostics and Pharmaceutical industry, offering a broad and unique array of products and capabilities. We are experts in the development, tech transfer, registration, manufacturing and commercialization of specialty diagnostics tests.
For contract development, what makes us different from others is that we are platform agnostic. What this means is that we will develop tests on any platform, depending on the requirements of our client. We will develop on any platform that meets the technical, clinical and commercial requirements of your customer. In addition, we pride ourselves on our project management skills and our robust quality management system. All of our development projects are conducted under strict design controls, with a focus on meeting promised timelines and budgets. We also help our partners with FDA and international registration processes and commercialization. In
addition, we provide assay validation services, reproducibility and bridging studies.
For contract manufacturing, quality is the key differentiator. We are ISO-13485:2016, an FDA registered facility and GMP compliant. We produce private label tests as well as our own product lines in our Broomfield facility.
Corgenix also has an on-site CAP/CLIA certified laboratory. Whether you need support for research or clinical trial testing or routine clinical testing services, we are here to help.
