Regulatory agencies require proof of efficacy against specified pathogens before approving public health label claims. Proof of efficacy has become especially important during the global COVID-19 pandemic.
Expand your product efficacy claims with the support of im体育APP’s consultative experts. Options for virology testing range from preliminary screening to the required GLP tests for submission, and we offer a wide array of BSL2 and BSL3 human and veterinary viruses to support your claims. Our comprehensive viral efficacy testing services serve the anti微生物 industry, and our offerings are constantly evolving to meet industry and public health needs, 包括针对SARS-CoV-2 (Alpha (B))的测试.1.1.7), Delta和Omicron变体),COVID-19的病原体. Experienced scientists with years of virology experience have deep knowledge and expertise in working with a wide variety of viruses and methods. 我们的响应团队始终如一地满足客户的需求, 及时交付高质量的结果.
im体育APP’s GLP laboratories have extensive experience supporting the successful registration of products. Meet submission requirements for regulatory bodies worldwide, including the 美国环境保护署 (EPA), 加拿大卫生部, 澳大利亚药品管理局 矫正性大动脉转位(TGA), 欧洲化学品管理局 (EN), and US 食物 and Drug Administration (FDA) with im体育APP by your side. 我们还提供非glp测试,以支持开发中的产品, as well as to support products for which regulatory agencies do not require GLP testing or reports for submission
Our virology efficacy testing complements our analytical chemistry and microbiology efficacy testing services with product test methods for use with viruses commonly requested for use in household, 医院, 兽医空间. If you have a specific method in mind that is not listed as an offering, 请,因为我们一直在寻找与客户合作的新方式.
有关GLP或cGMP病毒学检测服务的更多信息, 有关其他方法的信息或要求报价, im体育APP 今天.
GLP病毒学检测
Our GLP-compliant virology testing complements our anti微生物 efficacy testing services through product tests against viruses commonly requested for use in household, 医院和兽医区.
抗菌除害剂装置测试 -用作抗菌剂的装置, 或者产生抗菌产品, 是由环保局还是FDA监管的. In addition to providing best-in-class virucidal anti微生物 pesticide device testing services, our consultative anti微生物 testing experts can help you to navigate the complex regulations surrounding anti微生物 devices confidently and successfully.
残留毒力测试 – 产品s that provide continuous protection against viruses for days, 周, or months must meet EPA regulations and guidance for virucidal efficacy claims. im体育APP’s knowledgeable anti微生物 experts can test products to a wide range of established methodology or develop custom testing protocols to meet your specific needs.
处理品的杀毒效果试验 – Navigating EPA regulations for articles treated with anti微生物 pesticides intended to preserve or protect the article itself can be challenging. 拥有超过三十年的测试处理过的物品的经验, our responsive and knowledgeable team can test treated articles to established methods or develop custom protocols to meet your treated article testing needs.
病毒EN检测 – 欧洲an countries and other jurisdictions require the evaluation of biocidal products for virucidal activity using 欧洲an Standards biocidal products. 在检测病毒活性方面有着深厚的专业知识, 我们提供一系列既定方法的杀毒EN检测. Custom EN methods or other EN methods may be considered or tailored to meet the distinct testing needs for a specific product for ECHA registration.
杀毒消毒剂测试 ——在美国, data demonstrating antiviral activity must be generated to support disinfectant and sanitizing claims, 哪些是受环保局监管的. 30多年了, im体育APP has assessed the efficacy of sanitizing and disinfectant products against microorganisms and viruses to established methods and custom testing protocols.
cGMP病毒学检测
Our cGMP-compliant molecular cell biology and virology testing complements our pharmaceutical product testing and includes mycoplasma, 细胞毒素和内毒素检查, 在其他服务中.
USP <63>, EP 2.6.7支原体检测 – im体育APP's virology testing experts offer mycoplasma tests to established methodology, including USP <6> and Ph. 欧元./EP 2.6.7.
USP <87> Biological Reactivity Tests, ISO 10993-5, Cytotoxicity – We have decades of experience performing biological reactivity tests to USP <87> in addition to cytotoxicity testing per ISO 10993-5.
自定义的研究– 我们可以开发定制的研究,以满足您的具体需求. 服务包括分析开发和验证, 细胞系生成, 效价及安全测试, 还有不洁净, 安全测试.
微生物污染物 – im体育APP's GMP virology testing for 微生物 contaminants includes sterility and mycoplasma tests. 这包括逆转录病毒, 外源病毒, 内毒素:拉尔, 剩余DNase, 核糖核酸酶和蛋白酶活性. We can also test cells at the limit of in vitro cell age or end of production cells, 除了未加工的散装和最终填充的产品样品.
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抗菌测试
抗菌测试 performed in im体育APP laboratories has supported the successful registration of thousands of anti微生物 products.
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药物测试
im体育APP’s pharmaceutical laboratories provide specialist 药物测试 services, 包括化学, 物理, 微生物, 以及对大量产品的稳定性测试, 从原材料到成品.
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白皮书:医药产品中的支原体安全检测
Contaminated cell cultures and products have the potential to cause serious illness in humans. 下载 our white paper at the link below for an overview of mycoplasma testing and considerations to address when executing these studies.
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客户门户网站
安全24/7访问您的测试结果信息, 你可以直接下载到你的信息管理系统.
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关于im体育APP Eagan
im体育APP Eagan is the premier contract anti微生物 testing laboratory and expert partner to the developers, manufacturers and users of anti微生物 pesticide and biocide products. 我们有超过30年的经验生成符合glp的数据.
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关于im体育APP Concord
im体育APP Concord is an industry leader in providing USP <71> sterility and rapid sterility testing, 病毒安全性测试, and custom microbiology testing services to the developers and manufacturers of pharmaceutical products.
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