im体育APP offers Rapid Response services on bespoke investigatory analytical testing of pharmaceutical products. 从灵活的方法中获益, 快速周转时间, and precise results to ensure compliance and efficient resolutions.
什么是快速反应服务?
im体育APP’s industry-leading laboratories, 配备了最新的技术, specialize in comprehensive analytical method development and validation. Our mass spectrometry expertise and extensive problem-solving capability cover all aspects of pharmaceutical and consumer healthcare product testing including:
- Active pharmaceutical ingredients (API) & 最终药品
- 交付的设备 & 包装
- Biopharmaceutical single use systems (SUS)
快速周转时间
We are aware that pharmaceutical manufacturers often face urgent deadlines for testing and analysis that cause delays in product development or regulatory compliance issues. Our Rapid Response team collaborate closely with you to cater to time-sensitive requirements, ensuring 快速周转时间 to meet your urgent needs.
Complex testing for your analytical needs
Analyzing pharmaceutical and healthcare products is a complex process involving meticulous study design to identify impurities that require specialist evaluation. Our analytical laboratories specialize in comprehensive method development and validation, covering a wide range of analytical needs from impurity characterization to investigational problem-solving. Our Rapid Response solutions include investigations relating to:
- api
- 产品ion process related impurities
- 降解产物
- Residual solvents USP<467>
- 可提取和可浸出
- 外在污染
- im体育APP杂质- ICH Q3D
Identifying and solving your problems
Do you ever encounter difficulties in identifying impurities, 产品deformulation, or understanding the root causes of issues? Our investigational and problem-solving capabilities assist you in resolving complex analytical challenges efficiently. 它们包括:
- Extraction feasibility / solvent compatibility
- 峰鉴别
- 结构说明
- 强制降解
- 产品deformulation
- 根本原因分析
满足法规遵从性
Complying with regulatory standards for pharmaceutical products can be challenging and time-consuming.
Our services help you validate methods adhering to regulatory requirements and ensure compliance with industry standards set by agencies like the FDA (食物 and Drug Administration) or EMA (欧洲an Medicines Agency).
Advanced instrumentation for accurate results
Access to advanced instrumentation and expert knowledge may be limited, 阻碍综合分析. im体育APP boasts cutting-edge instrumentation and expertise across various analytical techniques, ensuring precise and accurate results every time. 我们的仪器包括:
- Waters Xevo QTOF-MS
- 安捷伦质/女士
- 安捷伦GC-MS(顶空 & 直接注入)
- 安捷伦icp
实现精确的, 及时的, and reliable analysis of your pharmaceutical products with im体育APP's Rapid Response services.
For 快速周转时间, precise results and efficient compliance resolutions, 立即im体育APP 简化你的分析需求.
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.
With a commitment to absolute certainty, we utilize our extensive expertise and experience to provide insights that ensure the safety of materials used in the life science sector.
im体育官方app下载相关页面
可萃取物和可浸出物研究
im体育APP's extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.
医疗仪器测试
作为全面的测试合作伙伴, you’ll enjoy the benefit of a single supplier source for all of your testing needs, from mechanical testing and environmental simulation to EMC and wireless device testing.
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, and stability testing on a vast array of products, from raw materials to finished products.
ISO 18562 测试: Biocompatibility Analysis
im体育APP provides ISO 18562 biocompatibility analysis for respiratory and ventilation devices to support global device approval.
USP 665, 1665和BPOG服务
Ensure compliance for single-use systems (SUS). Our testing services provide high-quality results, 保障病人安全, fulfilling your regulatory requirements, 加快上市时间.
Excipient Raw Materials and Container 测试
Find out how we make certain that quality and safety of your excipient raw materials and containers are maintained.
Chemistry, 制造业, and Controls (CMC) Consulting Services
We provide consulting services for Chemistry, 制造业, and Controls (CMC) product development in the pharmaceutical and biotechnological industries.
ICH Stability 测试 of 药品 and Biologics
We'll help you develop comprehensive stability programs that meet ICH Q1A-F requirements for IND, 安达, and NDA approvals of small and large molecule drugs.