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Kymos Group, S.L offer service "Method Development, Validation and Transfer"

基本信息

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交易类型

提供服务

服务名称

Method Development, Validation and Transfer

服务提供商

规格参数

  • 服务类型: 化学、生产及质量控制(CMC)分析方法的开发、验证与转移,适用于辅料、原料药、中间体及成品
  • 认证标准: 遵循ICH Q2(R1)和FDA指南,采用质量源于设计(QbD)策略;方法转移按照欧盟GMP第6章执行
  • 设备兼容性: 支持对比测试、两地联合验证或重新验证,以实现方法成功转移

其他信息

补充描述:

Kymos Pharma Services offers chemistry, manufacturing, and control analytical services in medicinal chemistry, including method development, validation, and transfer. Its team has deep experience developing and validating proprietary and non-proprietary methods for excipients, APIs, intermediates, and finished products, following ICH Q2(R1) and FDA guidance and applying QbD strategies to strengthen results. Methods are prepared for transfer to contract-givers in line with EU GMP Chapter 6, via comparative testing, co-validation across two sites, or revalidation.
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