CHEMISTRY MANUFACTURING CONTROL (CMC)
We provide senior CMC expertise to support the development of both biologics and small molecules, from early development through clinical phases to marketing authorization and beyond.
Our team helps identify CMC gaps, define pragmatic CMC strategies, and ensure alignment between manufacturing, quality, and regulatory requirements.
We support activities including CMC gap analyses, formulation and process development, stability strategies, specification setting, and preparation of regulatory documentation. Whether you need support for specific activities or an integrated project team, we offer flexible expertise tailored to your development program.
