(1) CMC packaging service including analysis service and stability research
(2) One stop service with high quality and efficiency
(3) Rich project experience and regulatory knowledge are conducive to the R & D and application of new and generic drug projects
(4) Research on GMP compliant methods and quality, including starting materials, intermediates, API method development and validation, preparation method development and validation, and release test of API
(5) Provide support services such as central control analysis for process validation and production:
          impurity separation and identification, structure confirmation of compounds
          characterization of chemical and physical properties
          standard calibration
          stability study in accordance with ICH / FDA / CFDA technical specifications

(1) have professional stability management personnel, special stability facilities and instruments.
(2) It has a calibrated stability test box, equipped with automatic call alarm and constant power system
(3) Complete stability research process, including scheme design approval, stability sample lofting and sampling, sample detection, data and trend analysis, and application data preparation
(4) Validation / transfer of stability research methods for APIs and preparations

         -20°C
         5°C
         25°C/60%RH
         30°C/65%RH
         40°C/75%RH
         50°C
(2) Light stability test <
(3) Support the writing of CMC project application materials for China and global application