We Transfer Data into Knowledge

Welcome to NiRACLE

Founded in 2009 ( as Nirvation), 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 products as well as manufacturing processes through historical data analysis, design of experiments (DOE), and multivariate modeling. NiRACLE’s unique ways of combining DOE with both statistical and chemometric modeling speed up product and process development and lower R&D 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.

Our Services

Case Studies

Tablet Content Uniformity

We have used a proven process to develop NIR assay methods for our clients for the determination of active pharmaceutical ingredient(s) in tablet dosage forms..............

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Process Validation

We have developed a proprietary multivariate modeling method that is named Supervised Principal Component Analysis (SPCA)........

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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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