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)