Bridging the Drug Substance and Drug Product Interface
With the ability to develop both Drug Substance (DS) and Drug product (DP) under the same umbrella, our team enjoys a synergism absent in most CROs. The ability to bridge the DS/DP interface is a major competitive advantage, and we are able to shorten development timeline and to improve ruggedness of the DP process.
Our technology platforms provide but are not limited to optimized API powder properties and improved aqueous dissolution as needed. We can effectively address issues affecting formulation early in Phase 1. This fundamental material knowledge forms the basis of our Quality by Design approach to improving Phase 2, Phase 3, and commercial processes.