In-process and release testing
Our QC group performs cGMP testing of raw materials, intermediates, and crude API including duplexes and conjugates. After manufacturing, QC performs all the necessary testing to generate a comprehensive certificate of analysis. We can also test drug product manufactured by a third party. Our cGMP lab is adjacent to our manufacturing suites, enabling fast turnaround times.
Comprehensive stability study services
Our experts can help you design a comprehensive stability study to meet regulatory guidelines for your drug substance or drug product. We have qualified on-site and off-site ICH sample storage to meet a range of temperature and humidity requirements. Our team will pull samples, perform testing, analyze the data, and provide a comprehensive report.
Reference standard testing
Nitto Avecia provides complete solutions for your reference standard needs. Our experienced chemists can produce high quality reference standards. Our QC group, in conjunction with our Analytical Development Group, can characterize, qualify and store reference materials for your project.
Our QC group provides process micro risk assessments and in-process micro studies to support your API. We also perform environmental sampling and monitoring of the in-house purified water system and the ISO-8 manufacturing areas. We have the resources in place so you can manufacture your drug substance at Nitto Avecia with confidence.