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Regulatory Affairs and Support |
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Regulatory Affairs and Support
PENTAPHARM's well-established SOP system and their up-to-date GMP trained staff ensure GMP compliance. Our facilities include class 100 clean rooms and large-scale lyophilization capacities. PENTAPHARM's FDA-inspected production facilities provide the structure for large-scale isolation and purification of API's, such as Aprotinin and Hemocoagulase.
PENTAPHARM offers a wide range of services:
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Process validation
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Validation of analytical methods
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Stability studies
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Process documentation
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Preparation of drug master files
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Filing of patent application |
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