Scientech’s stability studies and ICH storage services provide its partners with comprehensive support in drug product development, commercial stability studies, and batch release and quality control testing.
Scientech’s cGMP Stability Programs Ensure Product Development and Compliance from APIs to OTC Products.
Stability studies are studies of how Active Pharmaceutical Ingredients (APIs) react under the conditions of different environmental factors, such as temperature, humidity, and light.
Stability studies are a crucial part of the lifecycle of pharmaceutical and OTC products. They are especially vital in supporting the development process for New Drug Applications and Investigational New Drug Applications. Data from these studies provides information for recommended storage conditions, retest intervals, and shelf life.
cGMP compliant
FDA registered
DEA licensed
Documentation