Reference Standard Qualification
As your drug product progresses through the clinic, Althea will work on creating phase appropriate reference standards that set specifications and controls for assays used during the development of your product. Our team is able to bridge new lots of reference standards to demonstrate equivalence. Every time your drug product is manufactured, we will compare your drug product against the developed reference standards to determine that the product encompasses the same quality, purity, strength, and consistency. Compliance is also built into our review system, with our quality group reviewing test results and issuing Certificate of Analysis or Certificate of Release documents. By setting proper specifications for your reference standards, Althea will ensure that your drug product meets the same criteria for quality and consistency time after time.
PROJECT MANAGEMENT & BUSINESS PROCESS
Working with you from start to finish.
QUALITY & REGULATORY
Taking pride in our history of quality.