Stira Pharma has a dedicated stability and analysis group providing services for all stages of drug development, from early research and development to commercial and post approval studies. These services are provided in full compliance with International Conference on Harmonization (ICH) and U.S. Food and Drug Administration (FDA) guidelines.
Stira Pharma provides reliable stability storage monitored by a fully validated environmental monitoring system, and backed-up by a gas-powered electrical generator and UPS (Uninterrupted Power Supply) systems to enable continued data acquisition during power interruptions or brownouts.
Stability Storage and Testing:
We provide the following services:
ICH Stability Storage Conditions:
We can accommodate customized storage conditions outside of ICH as well.
Our temperature/humidity stability chambers are continuously monitored by a fully validated Environmental Monitoring System. It provides instant data regarding the individual storage condition while ensuring compliance with FDA 21 CFR 11. Our natural gas-powered roof top generator ensures continuous power during power failures for all stability chambers, fridges and freezers.
Compliance with Regulations:
Our services are performed in strict compliance with the requirements of: