About Us

Founded in 1994, Opus Regulatory is a leading regulatory affairs consulting firm serving biopharmaceutical companies throughout the US.

Opus Regulatory leverages a highly focused operating model designed to deliver a superior, cost effective solution for our clients' RA needs. We combine RA functional expertise, a network of thousands of regulatory professionals and 20 years' experience to deliver these services. Opus Regulatory consultants require little ramp-up time, allowing our clients to focus on their core competencies while minimizing the burdens of fluctuating workloads and shrinking budgets.

We're growing! For the 3rd year, Opus Regulatory was awarded a spot on Inc. Magazine's prestigious Inc. 5000 list. The list is the most comprehensive portrait of America's fastest growing private companies assembled anywhere.

Opus Regulatory has exceeded our expectations every time. The staff are dedicated and highly knowledgeable of the industry…consultants are exceptional and really fit the mold here. They are responsive to our critical timelines and deliver every time. SR Director of Regulatory Affairs