CMC and biomanufacturing support, from first-in-human to commercial supply

We are part of your team to manage CMC and GMP biomanufacturing topics, bringing an operational perspective on strategy, coordination and the decisions that follow, from CDMO selection or GMP facility implementation through to process validation and regulatory submission.

We run specific technical topics hands-on, including project management, process improvement and scale-up, tech transfer with its risk assessment and comparability studies, Quality by Design implementation, and process validation strategy from process design through continued process verification.

We support you on a defined question when you need an outside view backed by experience and benchmark: due diligence, technology assessment, troubleshooting, audit.