As your programs move from early to mid/late phase, we offer a unique model of accelerated process development that ensures your processes are Phase 3-ready. We leverages our extensive experience and deep engineering knowledge to develop project-specific plans that combine focused experimentation, statistical principles, and mechanistic modeling and simulation to ensure process robustness and process fit. We are committed to using any technology that best suits the process and your manufacturing constraints.

Our experience scaling up, creating appropriate scale-down physical models, developing, and filing processes for numerous small and medium size molecules globally (FDA, EMA, MHRA, Health Canada, SwissMedic, PMDA, etc) allows us to identify potential challenges and plan effectively and efficiently to minimize the risks associated with them.

We cover the entire development spectrum, from the understanding of the underlying mechanisms (kinetics, thermodynamics) to the definition/justification of efficient process control strategies using accepted QbD approaches that can be filed. Our approach can be successfully applied to the development of starting materials, pharmaceutical intermediates, drug substances, and co-processed materials.

We can also help you troubleshoot legacy projects to understand (retrospectively) observations and find strategies to avoid future issues at scale.

Small molecules

Tides