We offer a comprehensive array of analytical testing services and expert scientific consultancy from our GMP/GLP and ISO/IEC 17025 accredited laboratories, to meet the needs of clients across the life sciences sector.

 

什么是分析测试?

Analytical testing within the life sciences industry involves the examination of substances, 化合物, or materials to understand their chemical composition and behaviors.

 

为什么分析测试很重要?

Analytical testing is required to meet regulatory compliance set by agencies like the FDA (食物 and Drug Administration) or EMA (欧洲an Medicines Agency). It is a critical process within the product development of 医疗设备和医药产品 to evaluate and mitigate potential toxicological risks for patients or end-users.

 

The benefits of analytical testing with im体育APP

  • 定制的支持: We prioritize your requirements by ensuring unique needs are met through a personalized testing process. We advise on appropriate analytical methodologies that span customized testing 方法 and research protocols to ensure precise results and problem-solving for your manufacturing challenges.
  • 法规遵从性: Strict adherence to regulatory standards ensures compliance throughout the testing process. Maintaining the utmost levels of technical and regulatory compliance is our priority.
  • 专业技术: 我们的分析化学团队技术精湛, ensuring the highest technical standards and detailed feedback to support your product development and process innovation.
  • GxP合规: Adherence to current Good Laboratory Practice (GLP) and Good 制造业 Practices (cGMP), assuring test quality and regulatory standards are met.
  • 全面的项目管理: 从R&D, 制造业, 验证, our testing services encompass the full lifecycle of anti微生物, 生物制药, 食物, 医疗设备和医药产品, 为客户提供一站式解决方案.
  • 咨询及培训: You'll have direct access to our technical team for any issues with products, 方法, or anything relating to chromatography and analytical chemistry. We have a wide selection of ready-made training courses available as well as the resources to tailor courses to your specific requirements.
  • 无缝的转换: Coordination of analytical testing and efficacy testing ensures a smooth transition between testing phases.
  • 产品注册支持: Our testing supports registration for anti微生物 products like disinfectants and sanitizers, a critical aspect for market entry and compliance. 
 

确保产品合规性 

Navigating compliance challenges can present difficulties in product and drug development projects. We help 制药 manufacturers screen drug active ingredients, 检查包装材料, the chemical analyses of 制药 containers and stoppers, and the analysis of raw materials used in manufacturing processes. 医疗设备制造商, our analytical testing ensures materials meet stringent standards to minimize the risk of biocompatibility issues.

 
尼克·莫理

尼克·莫理

Principal Scientist for im体育APP 生命科学 EMEAA

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莎拉Brophy

Global Scientific Director for im体育APP's Extractable and Leachables services

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分析测试服务

我们还经营着一个全球网络 环境测试 laboratories for environmental compliance and management.

 

为什么选择im体育APP?

im体育APP is not just any GLP and cGMP analytical chemistry testing company. 在抗菌剂领域有着深厚的专业知识, 制药, 生物制药, 和食物, 医疗设备, 以及制药im体育平台app下载, we offer our clients full product and analytical testing solutions throughout the compliance process.

For more information about our analytical testing services, or to request a quote, 立即im体育APP.

分析评价阈值

生命科学

Check out our 生命科学 thought leadership content including webinars, 白皮书, 案例研究、博客等等.

由我们的im体育平台app下载专家撰写, we tackle a range of subjects across 抗菌, 生物技术食品, 医疗设备, 制药, 和个人护理im体育平台app下载.

带着对绝对确定性的承诺, we utilize our extensive expertise and experience to provide insights that ensure the safety of materials used in the life science sector.

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相关服务

药物检测科学设备

分析方法开发和验证

im体育APP provides innovative analytical method development and validation solutions to regulatory guidelines for a wide range of analytical technologies.

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抗菌测试

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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分析测试

生物分析法的支持

im体育APP’s comprehensive bioanalytical testing services are dedicated to bringing industry-leading scientific expertise to help customers advance drug development programs.

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生物制药和生物制品测试

生物制药和生物制品分析

im体育APP’s significant expertise in all stages of biologics R&D, from in-house protein biochemistry and molecular biology to cellular biology and QC experience, supports the entire product development life cycle.

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连接im体育APP生命科学.

Chemistry, 制造业, and Controls (CMC) Consulting Services

我们提供化学咨询服务, 制造业, and Controls (CMC) product development in the 制药 and biotechnological industries.

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Bioceuticals

可萃取物和可浸出物研究

Our extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.

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药物测试

药物测试

im体育APP’s 制药 laboratories provide specialist 药物测试 services, 包括化学, 物理, 微生物, and stability testing on a vast array of products, 从原材料到成品.

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药物检测科学设备

微量金属服务

im体育APP is a recognized world-leader in trace metal analysis, providing testing for elemental impurities by ICPOES and ICPMS in compliance with USP, EP (2.4.20),以及ICH Q3D指南.

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我们的团队超过9人,在北美聘用了000名专家, 欧洲, 中东地区, 澳大利亚, 亚洲和非洲随时准备帮助你们.