Keystone Biologics Advisory can successfully execute all of the following CMC advisory services:
IND-enabling CMC strategy (Module 3)
CMC readiness assessments for First-in-Human (FIH) clinical studies
CMC gap analysis for BLA
CMC support for FDA pre-IND briefing package
CMC Drug Development plans
Oversight or authoring of Module 3 IND
Comparability exercise
Control strategy and specifications development
Review of stability protocols and data
Keystone Biologics Advisory can successfully execute all of the following CMC advisory services:
IND-enabling CMC strategy (Module 3)
CMC readiness assessments for First-in-Human (FIH) clinical studies
CMC gap analysis for BLA
CMC support for FDA pre-IND briefing package
CMC Drug Development plans
Oversight or authoring of Module 3 IND
Comparability exercise
Control strategy and specifications development
Review of stability protocols and data
