Your production equipment, manufacturing processes, control instrumentation and laboratory automation are paramount to producing a controlled-cost, high-quality drug delivery device. Your qualification and validation approaches can make or break your timeline and inspection readiness.
We can help you to devise your manufacturing strategies and plans with our specific experience. We have developed scale-up and manufacturing strategies, scenarios and plans across many recent projects. We are very familiar with the key considerations and can apply these to your particular situation.
We can advise on Design For Manufacture (DFM), manufacturing equipment specification, equipment qualification, Process Validation, calibration and maintenance schedules and other approaches based upon your specific manufacturing scenario.
Our technical experience can also be applied to management of technical changes and critical process parameters, or performance of in-depth technical issue investigations.
We have established working relationships with many equipment providers and CMOs in the industry. We can work with any such partners at your request.
Please contact us to discuss your needs.