Overview

Founded in 1994, Opus Regulatory is a leading regulatory affairs contract consulting firm serving biopharmaceutical companies throughout the US. We leverage a highly focused operating model designed to deliver a superior, cost effective solution for our clients’ RA project needs including Regulatory Strategy, Labeling and Advertising & Promotion.

In a word, the Opus Regulatory model is unique. Headquartered in Cambridge, MA the firm is made up of ~50 FTE (remote-based) consultants specializing in Regulatory Strategy, Labeling and Ad Promo.

Our people have an average of 17 years pharma/biotech industry experience and are at the Associate Director to Senior Director level. We pride ourselves in being hands-on and able to adjust quickly to new teams and projects.