Calibration Set
About Calibration Set
ALTIUS Advisory designs and develops scientifically robust calibration sets that form the foundation of accurate and reliable NIR methods. We ensure that the calibration set adequately represents product variability, including raw material differences, process variations, and expected quality attribute ranges, to deliver consistent and predictive models. Our calibration set development follows regulatory guidance, cGMP requirements, and applicable ICH and USP standards.
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.