About

What we do

At Marble Pharma Consult, we help bring complex molecules from development to patients. Our core strength is peptides, and we also work on peptide conjugates, ADCs and other complex synthetic molecules. We support the whole CMC journey for both drug substance and drug product: phase-appropriate CMC strategy, process development and scale-up, technology transfer, GMP manufacturing, quality control and stability. We then carry that through to the regulatory CMC documentation needed for clinical trials and marketing applications, including answers to health authority questions. Our aim is to turn CMC complexity into a clear strategy and a practical plan that keeps programmes on time, compliant and on budget.

Who we work with

Because we have worked on both sides of the table, we support both sponsors and manufacturers. For biotech and pharmaceutical companies, we select and qualify the right CDMOs and run quality audits. We also negotiate quality and supply agreements, carry out technical due diligence, and manage outsourced operations day to day as part of your team. For CDMOs and fine chemical manufacturers, we help strengthen development and manufacturing operations and put operational excellence and Lean practices in place. We also help build the client-focused organisation that sponsors look for. On either side, the result is stronger partnerships, fewer surprises, and robust processes and products.

Sustainability

Last but not least, we measure the environmental impact of manufacturing and supply chains through life cycle assessment and carbon footprinting, including a predictive LCA approach for peptides that lets you compare routes, technologies and suppliers before scale-up. We then turn that into reduction roadmaps, greener chemistry built into process development and technology transfer.