| Do you want to introduce PAT (Process Analytical Technology) for: |
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A currently marketed “robust” product to
improve efficiency? |
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A currently marketed product that
needs improvement? |
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Development of your new product in either
early stage to define design space within
scale up activities? |
Our expert Dr. Weiland will help you
implement PAT in your regulatory process.
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| Our expertise is: |
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Dr. Weiland being steering committee member of
AAPS Focus Group on PAT chaired by Chris Watts,
CDER, FDA member of the FDA / PAT team |
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History of PAT applications in lyophilisation – solid
dosage form – various projects |
Use of risk based approach to apply PAT during
development for identifying gaps in your process
understanding.
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