Analytical Development

Our Analytical Development Team has extensive industry experience in the development, optimization and validation/method transfer, in accordance to ICH and FDA guidelines, of analytical test methods for drug substances and drug products. 

Our team has developed, optimized, and validated countless stability-indicating test methods for the determination of assays and impurities in drug substances and drug products. 

We have practical experience in developing analytical control strategies for the determination of potential genotoxic impurities in drug substances and drug products as well as regulatory starting materials and intermediates.