Comprehensive CMC dossier template, regulation/guideline and CMC knowledge sharing platform. Continually monitor and interpret laws/ regulations/ guidelines to ensure product compliance throughout the lifecycle
Core team members came from health authority, MNC or leading CDMO, with over 25yr biologics registration and regulation experience
Core team members frequently share expertise at industry conferences, actively participate in shaping the regulatory environment shaping, and have established strong connections with health authorities and industry associations
· 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
