aurisco pharmaceutical co., ltd.-凯发app下载

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