Independent of development stage, we offer a flexible, accelerated process development model designed to meet your program’s needs while building toward commercial readiness. We leverage extensive experience and deep engineering expertise to develop project‑specific plans that integrate focused experimentation, statistical principles, and modeling and simulation to ensure process robustness and fit‑for‑purpose design. We are committed to applying the technologies best suited to each 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.