Different by Design

Regulatory Strategy | CMC | Labeling | Ad Promo | Medical Review & Information

What is opus?

Opus Regulatory is a niche consulting firm with a team of over 100 full-time, remote-based employees, Opus has built a strong reputation in the pharmaceutical and biotechnology sectors, offering expertise across five core pillars: Regulatory Strategy, CMC, Labeling, Advertising and Promotion, and Medical Review & Medical Information. Our broad service offerings empower clients with the targeted, high-quality expertise they need at any stage of development.

Strategy

CMC

Labeling

Ad Promo

med Review & info

Who is Opus?

Our team is made up of biopharmaceutical leaders and innovators. Our mission is to provide the highest-level Regulatory & Medical Affairs services in the industry and to continually exceed the expectations of our clients.

Experience

Average tenure 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.

WHAT OUR CLIENTS ARE SAYING

"Throughout our collaboration, I was consistently impressed by the consultant's tenacity, work ethic, and commitment to excellence. They made meaningful improvements to our day-to-day operations and played a pivotal role during a particularly high-pressure launch period."

—Director, Regulatory Affairs
"Opus is a well-organized and dedicated Regulatory affairs consulting company that not only provides great Regulatory support, but manages their projects and billing well. I have appreciated the experience level of their consultants and how integrated the consultants are with the project teams.”

—Senior Director, Regulatory Affairs
"Our team is becoming a well-oiled machine and the Opus component only helped to achieve this goal. They each provide expertise, professionalism and best of all, great collaborative personalities. I’m truly enjoy working with them all."

—Senior Director, Regulatory Affairs
"Thank you for being one of the best reviewers I have ever worked with. You stepped in at a challenging time, we had tight deadlines but you made it so calming, you sought to problem solve and elevated our process. We are very grateful to have had you at such a critical time!"

—Vice President, Regulatory Affairs