CMC dossier suitable to the stage of clinical development of your product
In close collaboration with you, our Regulatory Affairs team will write a phase appropriate CMC dossier to support the clinical development of your drug product. Our team excels in writing and facilitating responses to questions raised by global health authorities for clinical trial and license applications.
Streamline CMC product design and development
Our proprietary technology-selection methodologies, predictive models, reference tools, flow-chart methodologies, testing methods and process equipment enable streamlined product design and 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. A robust control strategy is implemented to ensure a quality-by-design (QbD) approach and seamless scale-up to commercial manufacture.