Impurity isolation and identification in active pharmaceutical ingredients (APIs) and pharmaceutical drug products (DPs) is a critical aspect of the development process. The need to meet the quality guidelines outlined by the ICH (International Conference on Harmonisation) and adopted by regulatory agencies worldwide would be the most obvious reason. But […]
Picking and choosing CROs and CDMOs based solely on cost can ultimately raise project costs and slow your drug development and commercialization. Several weeks ago, we were approached by a company seeking an initial preparation of 20-25 grams of an API. They were a small pharma firm, with a limited […]
Pharmaceutical solid state chemistry – the study of functional relationships between the synthesis, structure, and properties of solid phase materials – plays a crucial role in successful drug development and commercialization. As active pharmaceutical ingredients (APIs) have grown more complex, the importance of understanding the polymorphic landscapes have, as well. […]
Welcome to the Regis Technologies blog, where we’ll be sharing news and information about our custom pharma contract development and manufacturing services as well as our portfolio of chromatography columns and specialty reagents. Regis Technologies, Inc. partners with pharmaceutical and biotechnology companies to help expedite their drug candidates to market. […]