About

The pursuit of US FDA marketing authorization for a novel medical device, or keeping an on-market product in good regulatory compliance, is a challenging but rewarding endeavor that requires a collaborative, team effort.

Our core expertise is providing regulatory insights and efforts to these complex development programs. We work with companies of all sizes, in all stages of product development, and across most therapeutic areas. We pair our deep knowledge of the regulations as well as the current regulatory environment with a practical understanding of the medical device industry.