cGMP FDA

CMC Expertise

As your Chemistry, Manufacturing, and Controls (CMC) partner, Xseer Pharma acts as an extension of your team to guide projects from concept to market. Our experts understand the intricate interdependencies between a drug’s chemistry, the manufacturing process, and the necessary quality controls.

We provide strategic CMC planning and documentation to support each phase of development – from preclinical trial material preparation and IND-enabling studies through clinical trial supply and eventual commercial manufacturing. By harmonizing formulation, process development, and analytical controls, we help streamline your path to regulatory approval. Our nimble approach means we can adapt to project changes quickly, ensuring you receive personalized support and solutions at every milestone.

CMC Expertise