Different by Design
Regulatory Strategy | CMC | Labeling | Ad Promo
What is opus?
Opus Regulatory is a niche Regulatory Affairs consulting firm providing experts in Regulatory Strategy, CMC, Labeling, and Ad Promo. Our clients range from development stage biotech companies to mid-size and large pharmaceutical companies.
Strategy
CMC
Labeling
Ad Promo
Who is Opus?
Our team is made up of biopharmaceutical leaders and innovators. Our mission is to provide the highest-level Regulatory Affairs consulting service in the industry and to continually exceed the expectations of our clients.
Experience
Average tenure in Regulatory is 17 years, the majority at the Director-level and up.
Leadership
We are leaders, whether it’s running a department, group, or leading interactions with Health Authorities.
Work Style
Versatile, hands-on consultants who can easily adjust to company size.
Core Values
It’s not just WHAT we do, but HOW we do it.
PASSION
We love what we do and it shows through the quality of the work we deliver.
EXCELLENCE
Serving our clients with solutions-oriented guidance
INTEGRITY
Building trust through honest relationships
RESPECT
Interactions rooted in listening, with compassion, kindness and caring
ACCOUNTABILITY
It’s simple. Doing what we say we are going to do, time and time again.
experience counts.
Knowledge is power and we’ve got the experience on our team to make a difference for our clients. We collaborate, get stronger and more experienced every day.