F2I Partners LLC

CDMOs are incredible partners. But you can outsource: ✅ Execution support ✅ Facilities + equipment ✅ Even documentation You cannot outsource: ❌ Product ownership ❌ Patient safety ❌ Executive accountability When the FDA walks in, they’re not asking: “Did your vendor promise quality?” They’re asking: “Show me your evidence of control.” Bringing in experts reduces risk. Abdicating responsibility compounds it. Strong programs maintain: ✔ Transparent governance ✔ Defined decision