Ensure Quality, Support the Development and Manufacturing of Your Products, Achieve Compliance With Your Standards

Our internal and qualified external testing laboratories enable GRAM to provide rapid turnaround for microbiology and analytical testing of raw materials, components and in-process and finished products, as well as stability samples. Our analytical development, validation and analytical testing services include:

  • Drug substance and reference standard material characterization
  • Reference standard qualification
  • Cleaning verification/validation
  • High performance liquid chromatography (HPLC)
  • Gas chromatography (GC)
  • Wet chemistry testing
  • Container closure integrity testing
  • Particulate matter in injections (USP <788>)
  • Endotoxin testing (USP <85>)
  • Total aerobic microbial count (USP <61>)
  • Total yeast and mold count (USP <61>)