The cornerstone of any product development and manufacturing effort is the analytical characterization and validation of all raw materials, bulk solutions, in-process materials, and finished product.
Our well-designed analytical programs satisfy regulatory requirements and work to assure the success of the clinical program. Our dedicated analytical scientists customize phase-appropriate analytical programs to the specific needs of your unique molecule delivering a comprehensive understanding and characterization of the molecule for each stage of development and commercialization.
Our on-site laboratories are equipped with sophisticated analytical instrumentation, enabling scientists to employ a full range of methodologies and techniques to characterize your product and develop test methods that will validate your product’s integrity throughout its life cycle.
Analytical testing services for product quality are done in conjunction with our contract manufacturing services.