CDMO Strategy & Due Diligence

De-risk CDMO selection before delay, quality failure and margin leakage become visible.

A stage-gated technical and commercial assessment of formulation capability, transfer readiness, scale-up, packaging, quality systems and operating reliability.

Capability fit

Does the CDMO have the formulation, process, analytical, packaging and regulatory capability required for the brief?

Scale-up risk

Which critical process parameters, raw-material dependencies and equipment differences threaten reproducibility?

Commercial economics

MOQ, yield, conversion cost, lead time, payment terms, rework and cash conversion.

Governance

Specifications, change control, deviations, testing, stability, documentation and accountability.

Engagements

  • CDMO shortlist and qualification
  • Technical diligence for PE, M&A or strategic investment
  • Technology-transfer readiness review
  • Batch failure and delay root-cause assessment
  • Claims and product-performance risk review
  • Commercialization governance design

Low-friction starting point

Use the CDMO Due Diligence Checklist before commissioning a full technical review.

Get the checklist