Feasibility
About Feasibility
ALTIUS Advisory conducts comprehensive feasibility studies to determine the practicality and success potential of NIR method development for a given product or process. We evaluate critical factors such as sample variability, chemical and physical attributes, process conditions, and data availability to assess whether NIR technology is suitable for the intended application. Our feasibility assessment is carried out in accordance with regulatory expectations, cGMP requirements, and relevant 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.