driving programmes
to the clinic
“When your Board discusses CMC, you know you have a problem.”
— Joan Perelló Bestard, Ysios Capital
For any biotech company, the focus naturally lies on the target, mechanism of action, preclinical models, and clinical-study design. Yet even strong science can be undermined by overlooked CMC challenges, causing significant delays, unexpected costs, and avoidable setbacks.
Chemistry, Manufacturing and Controls (CMC) is fundamental to drug development, from the earliest stages through to market approval. It covers everything from the manufacturing of drug substance to final product formulation and packaging, ensuring that the drug meets required quality standards. Adherence to regulatory guidelines is essential to secure approval for your Clinical Trial Application. A robust CMC strategy from the beginning plays a vital role in minimizing risks and reducing costs across all phases of drug development.
What does stage-appropriate development look like?
- Early clinical development
CMC is almost always on the critical path to initiating a Phase 1 study. At this stage, the goal is to establish a fit-for-purpose CMC package and avoid overdeveloping your product. Where scientifically and regulatorily appropriate, limit changes to the API synthesis and use a simple formulation with a stability program sufficient to support the planned study. Identify potential gaps in the IMPD early and address them through a focused, risk-based strategy during regulatory review, rather than re-engineering the entire programme upfront. This approach helps control cost and timelines while preserving the flexibility to refine the process and formulation as clinical knowledge develops.
- Late stage / exit preparation
A Phase 3-ready asset can be critical to valuation and transaction success. At this stage, demonstrate that the manufacturing process, analytical methods, quality systems, and supply chain are reliable, robust, and scalable, with sufficient product available to support pivotal studies.
The objective is to deliver a well-characterised, transfer-ready programme that enables a potential buyer or partner to “hit the ground running”—without major CMC, regulatory, manufacturing, or supply-chain surprises. Clear documentation, qualified suppliers, appropriate technical agreements, and a credible development plan are essential to support due diligence and maximise the asset’s value.
Every biotech needs a CMC person on the team—someone who can align clinical supply needs, identify synthesis and manufacturing risks, and provide clear, credible responses to health-authority questions. A dedicated CMC voice in the room where decisions are made.
Investors and boards increasingly view CMC readiness as an indicator of whether an asset can reach the market—and whether the investment case is credible.
We provide fractional CMC leadership that brings senior expertise, accountability, and strategic direction into your management team without the cost of a full-time hire.
What are fractional resources?
- “Part of a person” rather than “part of the job”
Fractional resources give you access to a senior specialist on a part-time or retained basis, without the cost of a full-time hire. You engage part of the person—not just part of the job: although the time commitment is limited, they take full accountability for their defined responsibilities. The arrangement is flexible and can scale up or down as your needs evolve.
- Embedded expert
Gain direct access to deep technical expertise and hands-on leadership within your team. Our seasoned professionals work as an extension of your organisation — driving results, and integrating smoothly without the commitment or overhead of permanent staff.