Deformulation and API characterization tend to be time- and resource-consuming processes as many generic companies lack the required resources to perform these crucial development steps. Our experts have a deep understanding of API properties, formulation composition, and predicting biopharmaceutical performance to efficiently support you throughout the development process. Understanding the challenges associated with analyzing samples and developing robust discriminating methods, SOTAX Pharma Services are available to assist you whenever you lack resources or expertise.
Three SOTAX Pharma Services laboratories in Europe, USA, and Asia are ready to help your development team to overcome the various hurdles of developing & registering a new generic product for commercial manufacturing. Set in a FDA inspected pharmaceutical establishment, our services and documentation ensure regulatory compliance at all times.
