Design of Experiments (DoE)
Recipharm offers drug substance development using a Quality by Design (QbD) approach, according to ICH Q11. This is now a requirement from all main global regulatory agencies and aims to minimise the risk of failure.
Process development and scale-up is extremely challenging and requires both synthetic chemistry and process engineering experience. Recipharm has strong expertise in both fields to ensure reproducible and robust processes, and that the right level of quality and process control are achieved no matter the scale.