Bio-Concept offers cGMP stability testing in compliance with pharmaceutical industry standards. We perform both full cGMP stability studies to support regulatory filings and cGLP stability screens in conjunction with formulation development. Best of all, all the support you need to test and release your product is on site, enabling your company to work with us from start to finish.
Precisely Controlled Environmental Chambers
Bio Concept is equipped with precisely controlled environmental chambers to simulate long-term temperature and humidity conditions according to ICH and FDA guidelines. In addition to traditional accelerated stability studies, we perform rapid degradation profiles of samples to quickly assess the product options. All of our chambers are connected to an alarm service for emergency notification.
Bio-Concept develops stability information that is added to the comprehensive documentation we prepare for each project. We even produce interim stability reports for clients to submit to the FDA as part of pre-IND and IND submissions.
Our Stability Program is designed to Store and Test your Product under ICH and FDA
Temperature and Humidity controlled conditions.