Provides customized laboratory and clinical manufacture services to pharmaceutical and allied industries

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ANALYTICAL DEVELOPMENT
 

  • Development and Validation of Stability Indicating Analytical Assay Methods for Active Drug Substances and Finished Dosage Forms
     

  • Forced Degradation and Stability Studies (ICH/FDA)

 

  • IV Admixture Compatibility and Stability Studies
     

  • Development of Test Methods and Specifications for Release Testing of Active Drug Substances and Dosage Forms
     

  • Release Testing including Compendial/Monograph Testing
     

  • Dissolution Test Method Development/Validation
     

  • Cleaning Validation Methods Development and Testing to support Cleaning Validation Studies
     

  • Analytical Development/Testing of Controlled Drug Substances, Schedules II through V, and their Formulations
      

  • Technology Transfers & Regulatory Documentation