Analytical and Regulatory Services

Analytical and Regulatory Services

Our comprehensive analytical services include purity testing, characterization of polymorphs, analytic methods development and validation, as well as stability testing. All analytical instruments and data are managed through the company's Laboratory Information Management System (LIMS) (.pdf).

Analytical services provided by ScinoPharm include:

  • Test method development and validation.
  • Quality control and release testing.
  • High performance liquid and/or gas chromatography (including purity assessment), separation of enantiomers and identification of impurities.
  • Stability studies for bulk active ingredients and formulated drug products, and preparation of regulatory documentation, including chemistry manufacturing and control sections of investigational new drug applications, new drug applications and drug master files.

Instruments of Analytical R&D and Services