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Services


 
MANUFACTURING OVERSIGHT AND BATCH RELEASE

Cirrus makes the transition to clinical manufacturing fairly seamless for the client. As needed, we assist with identifying an appropriate clinical manufacturing facility for the specific drug product. In preparation for the technical transfer to the manufacturing site, our staff can write and QA review the manufacturing monograph and batch records. If desired, Cirrus scientists can oversee subcontracted clinical manufacturing and commercial batch manufacture to help ensure a smooth transition. Batch release for clinical supplies and commercial products can be performed at Cirrus and release testing for raw materials and packaging materials can also be tested as per USP/EP guidelines.