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