The Systems-based Pharmaceutics Alliance (SbPA) aims to accelerate realisation of the Systems-based Pharmaceutics vision, increase adoption of the resulting tools and ensure their regulatory acceptance. Systems-based Pharmaceutics (SbP) is a holistic approach aimed at increasing R&D efficiency and maximising robustness in drug delivery and manufacture. The SbP vision considers drug substance manufacture, drug product manufacture and product performance as a single system. This reduces iterations between formulation and manufacturing process design, reducing costs and time-to-market. SbPA members work closely together in a pre-competitive relationship to develop integrated digital design techniques based on mechanistic models, verified by targeted experiments.