Our Services

Product Services

  • Screening and purification using high resolution MS and/or NMR for identification or de novo identification of related compounds

  • Support for primary and secondary confirmation of reference material

  • Detection, risk assessment, and guidance

Product Guidance

  • Method development, verification, and validation (including forced degradation) of the follow techniques:

    • High/Ultra-High Pressure Liquid Chromatography (HPLC/UPLC)

    • Liquid Chromatography- Mass Spectroscopy (LC-MS)

    • Nuclear Magnetic Resonance (NMR)

    • Gas Chromatography (GC) and GC Mass Spectroscopy (GC-MS)

    • FTIR and UV-Vis Techniques

    • Bioanalytical Techniques

      • ELISA, Western blot, MSD, SDS-PAGE

    • Capillary Electrophoresis

  • Determination and development of pharmaceutical targets such as ligand, receptor, and/or biomarker

Quality Services

  • Authorship and/or review of quality documents including Change Controls, Corrective Action Preventatives Action (CAPAs), Deviations, Laboratory Investigations, Standard Operating Procedures, etc.

  • Quality review of source laboratory data acquisition following ALCOA+ principles and current data integrity guidance

  • Authorship and/or review of regulated (CGMP) or non-regulated (non-CGMP) protocols, methods and reports