Medical Devices

Quality and Compliance

We bring a systems approach to GxP Quality operations. We view Quality Systems as a proactive technical platform designed to minimize errors, reduce risk and improve product quality - rather than just a reactive policing program in place to detect wrong-doing.

We typically operate in teams – which includes close cooperation with cross-functional CMC expertise for GMP projects -- as well as integrated GCP, GLP, GDP and/or GCP Quality Systems expertise. We have experience with products and their related Quality Systems requirements from early development through commercial stages across US, Canadian, European and various Asian GxP expectations.