We provide process route screening services according to various requirements, including innovative process route selection for generic drug, innovative drug process route development, ect.
Services for QTPP’s & CQA’s determination according to various product development requirements, CPP’s determination according to DOE experiments; Services for Pre-PPQ batch manufacture and process validation in compliance with CFDA’s & FDA’s regulations.
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Starting material-based synthetic route selection
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RSM-based route selection
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Cost-based route selection
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Process patent breakthrough/innovative process route selection
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Cost-based route selection
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Generic drug process route selection
Highly active drug process selection and development
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Meeting the needs of toxicology batch and clinical batch production and commercial production
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DOE experiments for process characterization to determine operating parameter ranges
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Process development based on Quality Risk Assessment (QRA), to determine critical process steps/parameters CPP/PAR/NOR
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Process development for pilot test, process transfer, and process validation