Bring senior CMC leadership to the program in the form the company actually needs.
Fractional CMC leadership
Executive CMC ownership for companies that need an experienced technical operations leader without immediately building a full internal organization.
Late-stage program architecture
A focused engagement to build the integrated CMC path from current stage through pivotal manufacture, filing and launch.
Critical technical workstream
Leadership of a specific high-risk problem such as scale-up, technology transfer, spray drying, dissolution or registration readiness.
CDMO and manufacturing governance
Senior technical oversight and governance across drug substance, intermediate, drug product, packaging and supply partners.
CMC diligence
Independent review of development maturity, technical risk, manufacturing network, registration readiness and critical path.
Executive and board advisory
Clear technical framing of CMC risk, options, timelines and investment decisions for executive teams and boards.
