Method Validation
About Method Validation
ALTIUS Advisory provides comprehensive method validation services to confirm that NIR analytical methods are fit for their intended use and deliver reliable, accurate, and consistent results. We validate critical performance characteristics such as accuracy, precision, linearity, robustness, and range, ensuring the method performs as expected under routine operating conditions. All validation activities are conducted in compliance with regulatory requirements, cGMP regulations, and applicable ICH and USP guidelines.
Altius Advisory
Approvals
Altius Advisory provides comprehensive guidance for the preparation and submission of complete and compliant documentation for NIR methods, ensuring alignment with current regulatory expectations and smooth approval processes.
Implementation
Altius Advisory partners closely with R&D, QC, QA and Manufacturing QMS to ensure a seamless transition from NIR method development to full-scale implementation. Our collaborative approach bridges the gap between laboratory innovation and commercial deployment, enabling regulatory readiness and smooth market release.
Support
Altius Advisory enables organizations to implement a sustainable lifecycle management strategy for NIR methods, supporting continuous improvement, regulatory compliance, and operational excellence.