The Chemistry, Manufacturing, and Controls (CMC) component is a critical element of the drug development process, and increases in complexity as the development process matures. The CMC includes manufacturing of bulk drug substance and final drug product, setting specifications, release criteria, stability programs, and analytical methods. Our seasoned experts, with decades of product development experience, can provide a critical roadmap to support your CMC program, beginning with a GAP Assessment to evaluate your current product development plan and continuing with long-term technical strategic planning and execution.В
We can design a product development CMC plan for your IND submission, as well as select, audit, and manage your contract manufacturing and testing laboratories, other service providers and suppliers.В Whether you need someone to manage the entire process or work on a task-based or troubleshooting assignment, we can provide support on the planning, execution, writing, and publishing of CMC sections for US and international regulatory submissions. We also have experience in conducting technical investigations to identify root causes of failures as well as in comparability study design. Our technical and regulatory expertise also streamlines your due diligence and technology assessment.
Additional descriptions of our CMC services are found in the attached PDF.