Small molecule drugs CRO/CDMO

Aurisco provides API CRO/CMO/CDMO service from drug discovery, clinical trials to commercial stage.

? 20+ years API manufacturing experience
? 200+ experienced R&D team, including 10+ PhD
? GMP system passed inspection by FDA
? RA support for worldwide

CMC solution

  • Pre-clinical
  • IND
  • Trial Ⅰ
  • Trial Ⅱ
  • Trial Ⅲ
  • NDA
  • Commercial
  • 01process development
  • 02API process optimization and validation
  • 03API manufacturing
  • 04synthetic service for IND
  • 05MOA development and validation
  • 06change control
  • 07produce sample for toxicology study
  • 08stability study
  • 09RA support
  • 10regulation consulting

Analytical service

  • MOA development and validation
  • Stability study
  • API working standard
  • releasing test
  • cleaning validation
  • characterization
  • microbiological test
  • Endotoxin test
  • Polymorph test

Equipment

  • HPLC
  • GC+HS
  • UPLC
  • Preparative HPLC
  • GCMS LCMS
  • NMR
  • UV FTIR
  • DSC/TGA
  • DSC/TGA
  • XRD
  • ICPMS

Our Advantage

  • Integrated experienced team: process, purification, analytical, manufacturing, QA/QC and RA
  • Well-equipped facilities
  • Strong support from GMP and EHS compliance, pass FDA GMP inspection
  • IP protection
  • Project management system
  • Faster response and Shorter lead time
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