Finding the right contract development and manufacturing partner is one of the most strategic decisions a biotech or mid-size pharma company will ever make. A poor selection can mean months of delays, lost batches, skyrocketing costs, sometimes at the worst possible moment: before an IND submission, before a Batch Release, before a critical out-licensing deal.
Yet in most RFP processes, the same classic criteria keep coming up: technical capabilities, certifications, price. Necessary? Yes. Sufficient? Absolutely not.
In this article, we offer a more comprehensive evaluation framework, the one our teams use to qualify our own projects, followed by a questionnaire to help us better understand your expectations and frustrations when working with CDMOs.
This is the logical first filter. But you need to look beyond the service catalogue displayed on a website.
What you really need to check:
The classic trap: a CDMO that has the equipment but not the expertise to use it in your specific context. Always ask to meet the scientists who will actually work on your project, not just the business development team.
A GMP certificate is a minimum requirement, not a quality guarantee.
The real questions to ask:
A strong CDMO should be able to provide you with:
✅ Their inspection history
✅ A list of supported dossiers by territory
✅ A named Quality contact from day one
This is where partnerships are made or broken.
A technically excellent CDMO that communicates poorly will cost you more than a slightly less sophisticated one that keeps you fully informed.
Warning signs to watch for:
What good looks like:
A CDMO that disappears mid-project, through bankruptcy, acquisition, or strategic pivot, is a major risk, especially for long-term programs.
Points to investigate:
A biotech with 15 people and an agile, fast-moving culture won’t thrive with a CDMO that operates like a large industrial bureaucracy.
Ask yourself:
The best partnerships are built on shared mindset, not just aligned specifications.
When applying this evaluation framework to Skyepharma, one of France’s most established CDMOs specializing in oral solid dosage forms, several strengths stand out.
Skyepharma has built recognized expertise in complex oral formulations : modified-release and targeted-release technologies as well as bioavailability enhancement. Our equipment portfolio covers the full development-to-commercial continuum, making scale-up transitions more predictable for sponsors.
With decades of experience supporting ANSM and FDA submissions, Skyepharma brings a solid regulatory foundation. Our quality systems are designed to support complex development, manufacturing and analytical projects.
As a mid-size CDMO, Skyepharma offers a human-scale relationship model with direct access to senior scientists and project leads, reducing the communication bottlenecks often experienced with larger contract manufacturers.
Our structure allow us meaningful responsiveness to protocol changes and timeline pressures. Something larger CDMOs often struggle to deliver without significant contractual friction.
Skyepharma presents a compelling profile for biotech and mid-size pharma companies working on oral solid formulations who value technical depth, regulatory experience, and a collaborative working relationship.