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Pharmaceutical and biopharmaceutical manufacturing includes products from raw material identification, cheimcal manufacture of intermediates, and manufacturing steps to the measurement of content uniformity. Moreover, the FDA, European Union and other regulatory guidelines have increased the focus on the use of quality initiatives and process analytical technology throughout the product development and manufacturing steps.
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Real-time measurement of product or process |
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Process Analytical Technologies (PAT) & Quality by Design (QbD) |
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Quantitative Analysis and Quality Control |
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Trace Results & Models |
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Standardize & streamline formulations
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- PAT and QbD project management
- Implementation and improvement of process control with multivariate analysis
- Multivariate Calibration Transfer between Near-Infrared Tablet Analyzers
- Integration of The Unscrambler® Technology into existing PAT environment
- Spectroscopic and Chemometric Analysis of raw material
- NIR
- Process analysis control using a NIR spectrometer
- NIR raw material identification
- In-line process analysis of residual moisture using NIR spectroscopy
- Identification of content uniformity in tablets by NIR spectroscopy
- Real-Time NIR Monitoring of Blending Process
- PAT monitoring of wet granulation process with NIR
- FTIR
- Reaction monitoring by FTIR: application of MCR for data analysis
- FTIR as PAT tool for increased process understanding and control
- Assessment of Herbal Medicines by Chemometrics - Assisted Interpretation of FTIR Spectra
- Crystallization process development and monitoring in the pharmaceutical industry
Services
- PAT & QbD
- Training: Multivariate analysis for Process Analytical Technology (PAT) and Quality by Design (QbD)
- PAT and QbD project management
- PAT development and implementation
- Integration of The Unscrambler® Technology into existing PAT environment
- Statistical and chemometrics training
- Design of Experiment expertise
- Process optimization expertise
- Quality control expertise
- Data analysis expertise
- Spectroscopy expertise







