Regulatory Affairs
Regulatory Affairs
Our service offerings:


Service scope:
Service advantages:
Service Advantages:
  •   · Comprehensive CMC dossier drafting capacity, supporting the project progress of various modalities during different stages of the product lifecycle.

      · Well-developed regulatory knowledge platform, regularly monitoring and understanding of regulation dynamics to ensure the continual compliance of projects.

      · Abundant global resources, efficient communication channels with regulators worldwide, and close collaboration with industry associations have been established.

  •   · Registration experience for multiple kinds of biologics, including eukaryotic and prokaryotic expression products, conjugation products, mRNA, etc.

      · Extensive experience in dossier preparation for biologics IND, BLA, and PAC application