Our Team
Diana M. Colleluori, Phd, MBA
CMC Principal Consultant
20 years of domestic and global experience in analytical methods, quality control, CMC regulatory affairs, and strategic planning in both start-up and growth organizations focused on biotechnology products, including cell and gene therapy products. Key technical experience includes potency assays, release and characterization assays, stability, specifications, raw materials, and all associated quality documentation. Direct experience authoring IND/IMPD and BLA/MAA sections and briefing documents.
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