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Quality CRO Platform

Analytical Method Development and Validation

Analytical Method Development and Validation

Our platform provides customized analytical method development and validation services. As a critical component of quality research, we conduct method development under scientific rigor, aligning with regulatory requirements (NMPA, FDA, EMA, ICH) and new technology application priorities. Validation protocols are designed in compliance with the Chinese Pharmacopoeia and ICH guidelines.

Validation Parameters Include:
  • Limit of Detection (LOD)
  • Limit of Quantitation (LOQ)
  • Specificity
  • Robustness
  • Linearity
  • Precision
  • Accuracy