Quality by Design (QbD)

TetraGenx Animal Health is the leader in applying the principles of Quality by Design (QbD) in drug product development and has helped fast-track clients’ submissions by implementing a cost-effective QbD approach. Responding to the FDA’s continuous requirement for improved process understanding and drug product quality, TetraGenx’s cross-functional team of industry experts assess and monitor process parameters that can affect the critical quality attributes of a drug product. By understanding how the critical quality attributes may affect the analytical result outcome, the efficacy and safety of the drug product can thus be assured.