in close collaboration with you, our Regulatory Affairs team will provide CMC regulatory solutions by writing a phase-appropriate dossier to support the clinical development of your drug product. Our team excels in crafting high-quality CMC regulatory submissions and facilitating responses to questions raised by global health authorities for clinical trial and license applications.
Our proprietary technology-selection methodologies, predictive models, reference tools, flow-chart methodologies, testing methods and process equipment enable streamlined CMC drug product development and smooth progression through all development stages.
At each stage of development, we work with you to identify the critical-to-quality attributes and important formulation and process parameters. CMC consulting services help implement a robust control strategy, ensuring a quality-by-design (QbD) approach and seamless scale-up to commercial manufacture.