Boston Analytical provides you with all the reports and annual stability studies data you need for the FDA filing of an IND or NDA registration. We offer stability protocols and consulting for the early stages of your drug development and clinical trials. As you gather data, we will help you adapt the clinical stability studies, to adjust to the nuances of your product and needs.

We leverage a LIMS system, to know exactly when samples are to be pulled; and, our stability experts safely record cGMP-compliant data in ELNs. With a 30-year history in pharmaceutical shelf life testing and numerous ICH-compliant stability chambers in our new facility, Boston Analytical has the corporate stability and facilities you need for all your clinical registration stability testing needs.