Ensuring your path to the clinic, we develop, execute and document phase-appropriate methods necessary to produce high-quality, well-characterized material and the data to support successful IND and marketing applications as you move towards commercialization.
Applying our expertise and experience, we develop data packages that support your regulatory approvals with all global agencies.
Our approach focuses on the development and qualifying phase-appropriate assays in support of:
Global Team of Experts
Our global team of expert analytical scientists develop analytical test methods and analytical qualification protocols, leveraging state-of-the-art instrumentation and a molecule-specific, customized approach to method development, qualification, and testing. Methods can be developed de novo or transferred in from external laboratories.
By understanding your molecules’ attributes, we support future development activities with customized characterization assays.
Once methods are established, we optimize and refine them for the molecule of interest as part of an integrated service that supports process, and formulation development, and/or bioconjugation.
Our Capabilities
Our capabilities include the following:
