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Transform Data into Knowledge
Welcome to NiRACLE
Founded in 2009, NiRACLE is an innovative Contract Research Organization (CRO), providing Near Infrared (NIR) method development, Process Analytical Technology (PAT), Quality by Design (QbD), and process validation support to the pharmaceutical industry. NiRACLE has pioneered the Supervised Principal Component Analysis (SPCA) technology, a novel multivariate data analysis approach that can be used in NIR-related quantitative analysis (US Patent No. US2011/ 0216313 A1).
NiRACLE’s services let the clients build high degree of assurance in their manufacturing processes through historical data mining, modeling, and trend analysis, identification of critical product and process attributes, design of experiments, and defining the design space. NiRACLE’s expertise will help clients to achieve key milestones, speed up product development, and lower R&D and production costs.
NiRACLE maintains strict confidentiality to client’s intellectual properties.
NiRACLE’s scientists are motivated to deliver the highest values to the clients. Together as a team, they will work closely with clients to generate the best possible results, project by project.
|Method Development||Process Validation||Troubleshooting||Material Identification||User Training|
|NiRACLE assists clients in developing NIR-based methods for both GMP and non-GMP applications. Non-GMP NIR methods take advantage of NiRACLE’s proprietary modeling method and designing a comprehensive sampling plan.||NiRACLE is specialized in multivariate data analysis, which plays a critical role in today’s process validation.NiRACLE works with clients in selecting suitable process monitoring methods and designing a comprehensive sampling plan.||Using NIR chemical imaging and multivariate data analysis tools, NiRACLE can assist clients in troubleshooting product and process related problems.||NiRACLE can help clients in developing a NIR-based raw material identification system to replace the conventional wet chemistry methods.||NiRACLE provides training in basic and advanced NIR/NIR chemical imaging related method development, which include proper use of instruments, experiment design and multivation...|
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