Stability Testing

Stability Testing


We Offer:

  • Analytical Methods Development
  • Stability indicating analytical methods development
  • Design validation protocols and perform validation studies of analytical test methods for pharmaceutical drug substances and drug products
  • Assist in complete tech-transfer of validated analytical testing methods for pharmaceuticals
  • Contract analytical testing services under cGMP/cGLP conditions
  • Stability testing as per FDA and ICH guidelines
  • Shelf-life assessment for drug substances and formulations
  • Complete regulatory and documentation support for FDA’s CMC sections for IND’s, New Drug Applications (NDA’s), and Abbreviated New Drug Applications (ANDA’s)