Framework + Stage-Gate Platform

A sponsor-side operating model with a stepwise stage-gate backbone.

CDMO Performance connects external manufacturing capabilities, gates, governance routines, scorecards, and recovery plans into one practical system for managing CDMO and CMO partnerships.

Stage-Gate Backbone

Teams can start at the beginning, or enter where the work already is.

New outsourcing programs may begin at G0. In-process technology transfers, active manufacturing campaigns, and existing commercial partnerships can be assessed at the appropriate gate and integrated into the same operating model.

G0 Stage Focus

Strategy Approval

Strategy + Network Fit

Confirm the outsourcing need, product scope, network fit, business case, and sourcing strategy before the sponsor commits to partner selection.

Core Outputs

    Enter at the right point. New outsourcing programs can start at G0, while in-process technology transfers can be assessed at G3 or G4 and integrated into the same governance, scorecard, and recovery model.
    Assessment-ready by design. Each stage and gate can become part of the future CDMO Performance maturity assessment, covering process maturity, data maturity, governance maturity, and recovery effectiveness.

    Domain Reference

    The hover panels show the active domain focus for each gate.

    The full framework still covers all external manufacturing management domains, but the stage-gate visual now reveals the relevant domains at the point where they matter most.

    DomainPrimary Gate RelationshipPurpose
    Partner Selection and Due DiligenceG1Select the right CDMO/CMO through technical, quality, regulatory, financial, capacity, and business-fit criteria.
    Contracting and GovernanceG2Establish the commercial, quality, technical, decision, and escalation structure for the relationship.
    Technology Transfer and ValidationG3Confirm process understanding, control strategy, risk assessment, readiness schedule, and validation planning.
    Manufacturing ReadinessG4Confirm methods, materials, documents, equipment, work orders, batch records, and training are ready for execution.
    Scorecards, WPI, Risk, and CIG6Use objective performance trends to drive partner development, recovery, renewal, expansion, transfer, or exit decisions.

    Next

    Turn the framework into a maturity assessment and implementation roadmap.

    Use each domain and gate to evaluate the current state, define the target state, and prioritize the buildout.

    View Assessment Model