Clinical, Registration, and Annual Stability
When outsourcing stability studies and contracting with a vendor for stability storage and testing, you want experience, flexibility, and longevity. Boston Analytical provides all three.
Our staff has been working on short- and long-term stability studies since 1987. You can be certain we will be here to perform the stability studies you need for the entire lifecycle of your product:
Clinical Stability Studies
We will help you design clinical stability studies for the early stages of your drug development and clinical trials. As you gather data, we will then help you adapt the clinical stability studies to adjust to the nuances of your product and needs.
Registration Stability Studies
It is vital that your registration stability studies are well-documented, since they provide the definitive stability data on your product to the FDA. Boston Analytical will provide you with all the reports and information you need for the FDA. With a 25-year history, we have the corporate stability you need for a long-term contract stability storage and testing relationship.
Annual Stability Studies
Annual stability studies are an on-going fact of life in the pharmaceutical market. We will handle all your annual stability studies like clockwork, delivering data and documentation to you in a timely manner.
Our facility meets ICH stability storage conditions, with redundant systems in place to ensure that your samples are pulled and tested at the right time, and a 24-hour alert system and maintenance staff to ensure the safety of your samples.