Science-First. Globally Aligned. Partner Ready.
CMC Wise is a UK-based regulatory and R&D services company specializing in small-molecule pharmaceuticals with a strong focus on complex injectables, orals, and sterile ophthalmics.
We combine deep regulatory expertise, science-led formulation development, and transparent engagement models to accelerate your path from lab bench to market.
Our team operates as an extension of yours — lean, senior-led, and globally aligned with EMA, UK MHRA, and US FDA requirements. Whether you are a virtual biotech or a mid-size pharma, we provide clarity, compliance, and commercial foresight at every stage.
Key Highlights:-
• Integrated CMC, R&D and Regulatory Affairs expertise
• Specialist in complex injectibles & lifecycle extensions (505(b)(2))
• UK-based with global reach (EMA< MHRA<FDA alignment)
• Flexible models: Fee-for-service & Co-Development
• CRO/CDMO partnerships for rapid mobilization
