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
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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)
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