CMCAssist ApS

At CMCAssist, we specialize in CMC consultancy, offering expert guidance on regulatory documentation, formulation development, and comparability assessments. Our CMC development solutions applies scientific and regulatory excellence to ensure optimal development of your drug candidate, from lead selection through preclinical, phase I and phase II We develop robust CMC strategies, providing detailed timelines, optimizing manufacturing processes, and securing formulation patents to protect your innovations. Our skilled writers craft high-quality regulatory documents, including IMPDs, INDs, and briefing documents, ensuring clarity and compliance to facilitate approvals. In addition, we can aid in CMO/CRO selection and management, aswell as perform important in silico analyses to aid in formulation development or lead selection. Focus areas: • Formulation, pre-formulation, characterization and comparability • Release specifications, in-use and shelf-life stability • Peptides, proteins and novel drug concepts • In silico degradation product and lead selection analyses • Quality strategy and documentation: IND, IMPD and quality overall • IMPD formatting • CRO and CMO selection and project management • Troubleshooting, root cause and risk assessment • Due diligence Please reach out on LinkedIn or leave a mail at info@cmcassist.dk, so we can discuss your personal needs.