At Ceyone Life Sciences, we follow rigorous validation protocols to ensure analytical methods are accurate, precise, specific, and reproducible in line with ICH and global regulatory guidelines. Once validated, our methods are systematically transferred to manufacturing or partner facilities through well-defined protocols, ensuring smooth adoption without loss of reliability or data integrity.
Key Highlights
Validation covering accuracy, precision, specificity, linearity, range, and robustness
Structured transfer protocols to ensure consistency across sites
Compliance with ICH Q2(R1) and international regulatory standards
Supporting documentation prepared for regulatory filings (IND, NDA, ANDA, DMF)