The generic product development ranges in complexity from oral solids to injectables with a focus on products that have a high entry barrier. The drug product development emphasizes on continuous quality at each step.
The teams specialize in formulation development, analytical method development & validation, technology transfer, and filing strategies for regulated markets (USFDA, EU, TGA, MEDSAFE, MCC). The teams and the facility are geared toward development of diverse dosage forms with a target on bringing value-added generic products built on Quality by Design (QbD) and compliance.
Teams work in an atmosphere that is completely empowered and have the full sense of ownership needed to bring the highest quality products to fruition.