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Process Analytical Technology (PAT)
Do you want to introduce PAT (Process Analytical Technology) for:
A currently marketed “robust” product to
improve efficiency?
A currently marketed product that
needs improvement?
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.

Our expertise is:
Dr. Weiland being steering committee member of
AAPS Focus Group on PAT chaired by Chris Watts,
CDER, FDA member of the FDA / PAT team
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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