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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