CRO Service
Expert Team：
● with 30+ years of experience；Full-process expertise in 100+ generics and 1,000+ clinical projects.
Specialize in complex formulations and 505(b)(2): ：
● Core tech including hot-melt extrusion, self-emulsification, pellet controlled release, centrifugal granulation.
Innovative IVIVC Reverse R&D Capability：：
● Specialized instruments and proprietary algorithms for rapid IVIVC conclusions.
Strong BE：
● Address challenges of poorly soluble, high-variability and narrow therapeutic drugs; NIDA-certified GCP team; High BE success rate；meet China-US regulatory submission.
Global Registration：
● Familiar with global regulatory requirements; Collaborate with 20+ manufacturers, with 200+ FDFs approved by FDA, EMA and NMPA.
