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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.