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Analytical & Regulated Projects

Go to Analytical & Regulated Projects

HOW CAN WE HELP YOU?

We support testing throughout the entire development process. We offer fully integrated pharmaceutical development capability. We develop and repurpose drug candidates and provide clinical supplies by means of our FDA inspected cGMP facilities. Our experienced organic and medicinal chemists, polymer scientists, chemical and electrical engineers and materials scientists can expedite novel solutions to pharmaceutical, regenerative medicine or medical device problems.

  • Instrumentation: UPLC-UV, HPLC with RI, ELSD, UV, PAD and MS detection. GC- direct injection or headspace analysis, triple quadrapole MS, QTof accurate mass spectrometer, Karl Fisher (coulometric and volumetric), particle size analysis (nano to micron range), osmometer, eSEM imaging, IR, TGA, DSC, XRD and NMR.
  • Project types: Assay, impurities, payload, release (immediate and extended), method development, method validation, residual solvents, extractable leachable, raw material testing, product release and ongoing stability.
  • ICH stability studies
  • Forced degradation
  • Impurity Isolation
  • Temperature cycling studies
  • Dissolution (USP types I, II and IV)
  • Reference standard characterization
  • Controlled substances – schedule II-V for research and manufacturing