Medical Devices

Quality and Compliance

We bring a systems approach to Quality operations, viewing Quality as a technical platform designed to eliminate mistakes and improve product quality, rather than just a reactive policing program in place to detect wrong-doing. We typically operate in teams, providing you with cross-functional CMC expertise for GMP projects, as well as GLP and GCP Quality Systems (Quality Assurance) expertise. We have experience with products from development through commercial stages and are knowledgeable with US, Canadian, European and various Asian GxP regulations.