When biotech companies seek funding—whether for a Series A, Series B, IPO, or strategic partnership—investors do not just look at clinical data.
They also carefully review CMC information (Chemistry, Manufacturing, and Controls) to evaluate whether the product is manufacturable, scalable, and approvable.
CMC readiness can heavily influence investment decisions. Here’s what you need to know to prepare for CMC due diligence.
Why Investors and Partners Care About CMC
- Manufacturability: Can the product be reliably made at scale?
- Regulatory Risk: Are there gaps that could delay approval?
- Cost of Goods (COGs): Will the cost of production allow for a viable commercial model?
- Supply Chain Robustness: Are critical suppliers and manufacturing processes secured?
In short, strong CMC equals lower risk and faster time-to-revenue.
Key CMC Topics in a Due Diligence Review
| Focus Area | Key Questions Investors Ask |
| Drug Substance and Drug Product Development | Are processes well-understood? Are there any red flags such as yield issues or impurities? |
| Manufacturing Strategy | Is the sponsor relying on a single supplier? Are backup plans established? |
| Process Validation Plans | Are approaches appropriate for the development phase and designed to support eventual licensure? |
| Control Strategy | Are critical quality attributes (CQAs) and critical process parameters (CPPs) clearly identified and controlled? |
| Stability Data | Is there sufficient real-time stability data to support claims? |
| Regulatory History | Has there been any significant agency feedback, Form 483 observations, or inspection issues? |
| CMC Risk Mitigation | Are risks identified early and addressed with realistic plans? |
Best Practices to Prepare Your CMC Package for Fundraising
- Organize CMC Documentation Early
Create a centralized data room containing key CMC reports, batch records, regulatory submissions, and summaries.
- Conduct a CMC Gap Assessment
Evaluate readiness for late-stage development or commercialization and identify remediation needs.
- Develop a Phase-Appropriate Control Strategy
Demonstrate that you are proactively thinking about scale-up and lifecycle management, even in early stages.
- Address Supply Chain Risks
Document supplier relationships, material sourcing strategies, and supply chain contingencies.
- Summarize CMC Risks Clearly
Investors respect transparency about challenges—paired with credible mitigation strategies.
Common Mistakes to Avoid
- Scrambling to compile CMC documents after diligence requests are received
- Underestimating the importance of real-time stability data
- Failing to define regulatory starting materials and justify them under ICH Q11
- Assuming that early clinical stage status exempts you from CMC review
Final Thoughts
CMC due diligence is not just a regulatory formality; it is a business critical assessment.
Investors and partners want to fund companies that manage technical, regulatory, and operational risks early and thoughtfully.
At DSI, we specialize in helping biotech companies prepare strong, defensible CMC packages for fundraising and partnership activities. We can also help you prepare fro due diligence reviews.
If you are preparing for an investor round, due diligence, or M&A activity, we can help you position your CMC program for success.
