Develop the technological foundation for vaccines, including high mRNA, DNA, adenovirus, and polymer vaccine technology pathways. Refine CMC production technology requirements, quantify antigen and adjuvant ratios, and optimize the structure of stabilizers, preservatives, and surfactants. Provide regulatory agencies with comprehensive efficacy studies and toxicological analyses.

CMC ensures that pharmaceutical and biopharmaceutical products remain consistently effective, safe, and of high quality for consumers. It bridges the gap between drugs used in clinical research and the commercial products available to consumers. CMC is not a generic checklist or set of tests applied to every product; rather, it is tailored to specific platforms and delivery systems (e.g., injectables, controlled-release, inhalables, topical formulations, solid doses, oral medications, etc.). Therefore, Decouvor's CMC Compliance Department has established a comprehensive CMC document review mechanism, including method development analysis, purification, and comprehensive collection and organization of characterization data to provide compliance data for regulatory authorities.

The Medical Device Department, in accordance with regulatory requirements, completes data preparation, submission, review, interactive Q&A, and post-approval market surveillance for in vitro, in vivo, and protective medical device companies. It also establishes medical device equivalence documentation to support regulatory compliance.