How to Vet a CDMO: A Due Diligence Checklist for First-Time Biotechs

How to Vet a CDMO: A Due Diligence Checklist for First-Time Biotechs

Choosing the right Contract Development and Manufacturing Organization (CDMO) is one of the most critical decisions a biotech company will make. Get it right, and you have a smooth path to IND and beyond. Get it wrong, and you're in for missed timelines, costly remediations, or worse—regulatory delays you didn’t see coming.

For large pharma companies, CDMO selection is guided by deep technical teams, vendor audits, and long-standing playbooks. But what if you’re a small or virtual biotech, navigating this for the first time?

At DavosPharma, we’ve helped emerging companies evaluate, select, and manage CDMOs across five continents. Whether you’re sourcing API, drug product, or both, here’s our no-nonsense checklist to make sure you don’t miss what matters.

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1. Regulatory Track Record

Ask:

• Have they passed recent FDA, EMA, or PMDA inspections?
• Are there any warning letters or import alerts tied to this facility?
• Do they hold valid GMP certificates for the type of work you need (API, DP, sterile, etc.)?

Why it matters:
Past performance is a strong predictor of future compliance. A great price doesn’t matter if your material can’t be used in a filing.

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2. Therapeutic and Molecule Fit

Ask:

• Have they worked with molecules in your therapeutic class?
• Do they have experience with your modality (e.g., small molecule, peptide, steroid, highly potent)?
• Can they handle your specific dosage form or delivery system?

Why it matters:
You don’t want to be their test case. Technical familiarity reduces startup time, risk of surprises, and costly scale-up rework.

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3. Analytical Capabilities

Ask:

• Do they offer in-house method development and validation?
• Can they support stability testing under ICH conditions?
• Are impurity profiling and genotoxic impurity assessments part of their core competencies?

Why it matters:
Your IND (and later NDA) will live or die on data. Weak or incomplete analytical work is one of the most common reasons for regulatory pushback.

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4. Project Management and Communication

Ask:

• Will you have a dedicated project manager?
• How often will you receive updates?
• Can you access raw data and documentation directly?
• Are you able to communicate with the scientists directly?

Why it matters:
Even the best facilities, things go wrong. What matters is how it is handled. Look for transparency, responsiveness, and a clear escalation path.

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5. Scalability and Timeline Fit

Ask:

• What is their lead time for your batch size and scope?
• Can they grow with your program (from tox to Phase 1 to commercial)?
• Are they currently backlogged or at risk of capacity constraints?

Why it matters:
Plenty of CDMOs will say yes—until they’re juggling bigger clients and pushing your project to the back of the line. Timeline delays kill value in early-stage programs.

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6. Quality and Documentation Culture

Ask:

• Do they have SOPs for deviations, CAPAs, OOS events?
• How do they manage raw data access, batch records, and QA review?
• Can they support audits (yours or from a sponsor)?
• How many audits from regulators and clients did they perform last year?

Why it matters:
If you don’t control the data, you don’t control the risk. A weak QA culture creates serious exposure downstream.

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7. Financial and Strategic Fit

Ask:

• What is their typical project size?
• Do they require minimum batch sizes or long-term contracts?
• Are their business practices aligned with your risk tolerance (e.g., IP, transparency, flexibility)?

Why it matters:
A technically sound CDMO that doesn’t value your business is still a bad fit. Look for a partner, not just a provider.

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Bonus: Red Flags to Watch For

• Unclear responses about regulatory inspections
• No established comparability protocols for scale-up
• Frequent project manager turnover
• “We’ve never done that, but we’re sure we can do it”
• Pressure to sign before seeing documentation or timelines

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Or Skip the Guesswork

DavosPharma has already done the due diligence on hundreds of CDMOs across the U.S., Europe, India, and China. We don’t just make introductions—we stay in the project, negotiate on your behalf, and make sure the work gets done right.

Whether you’re sourcing your first tox batch or preparing for commercial launch, we’ll match you with the right partner—and stay accountable every step of the way.

Need help evaluating a CDMO? Contact us for a free consultation.