Fractional CDO for Growing Pharma Companies

The CMC Depth of a Top-Tier Organization — Without Building One

For growing pharmaceutical companies past the startup phase — with real pipeline, real regulatory exposure, and the need for deep CMC expertise without the corporate overhead. Built on 30 years of experience that delivered dozens of programs at Pfizer, Abbott, Takeda, and Hospira, including one of the industry’s first real-time release solid oral NDAs.

Fluent in Global Regulatory Defense

FDAEMAPMDA

You have moved past the startup phase. You have a real pipeline, real regulatory exposure, and real commercial pressure. What you don't yet have is a full internal CMC infrastructure built for it. That is exactly the gap Cachet Pharma Consulting is built to fill.

Not corporate-scale solutions. Corporate-level thinking — across science, operations, and digital strategy — at a size you can actually absorb. Read about our technical approach or explore our analytical capabilities.

Featured Strategic White Paper

The Dissolution Specification Trap

When FDA tightened the specification, most teams would have fought back or quietly accepted the risk. We asked a different question — and it changed everything. Read the full case study on how a tighter limit became a competitive advantage.

Read the Case Study
"If we accept your specification, what has to change in our method to make it robustly achievable?"

The question that reframed everything

What We Bring

Three Pillars. One Integrated Perspective.

Most consultants operate in one domain. We operate credibly across all three simultaneously — which is what growing pharma companies actually need.

Science of Drug Product Development

Dissolution strategy, specification negotiation, DOE-based method development, Monte Carlo risk quantification, and QbD applied to real regulatory situations — not textbook scenarios.

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Management of Science

Linear Programming for portfolio optimization, Lean R&D, regulatory risk framed for leadership, and technical CMC due diligence — connecting the lab to the boardroom.

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Digital Strategy

Proprietary simulation and risk quantification tools deployed directly in client engagements. Predictive models, DOE as a digital enabler, and AI applied with scientific rigor and regulatory credibility.

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Operational Leadership

30 years of leading through complexity — restructurings, site transitions, crisis response, and building organizations resilient enough to execute under pressure. Leadership as the thread that runs through everything.

About Jean-Marie →

Ready to Talk?

The most expensive mistakes in pharma aren’t made at the bench.

They're made before you ever get there. If you want a candid conversation about where the real risks in your pipeline live, reach out directly.

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