Analytical Services for Chemical Development

  • TCG Lifesciences offers a comprehensive array of “Analytical Method Validation” and related studies for global regulatory submissions
  • Laboratory infrastructure includes a full array of analytical instrumentation meeting the 21 CFR part 11 requirements (DUNS # 651030913)
  • Development and validation of analytical methods for both drug substances and drug products as per the current pharmacopeia (USP, BP, EP, JP) or customer specified procedures and specification
  • Impurity identification and isolation by preparative HPLC and SFC
  • Characterization using 1H, 13 C NMR, LCMS, IR etc.
  • Well equipped laboratory to handle high potency drugs
  • Qualified and well-trained team to carry out the analytical study filings to USA, Europe, Japan and other countries