Who is Opus Regulatory?
Founded in 1994, Opus Regulatory is a niche consulting firm serving pharmaceutical and biotechnology organizations. Our team of more than 100 full-time professionals provides targeted, high-quality expertise across five core areas: Advertising and Promotion, Medical Review & Medical Information, Regulatory Strategy, CMC, and Labeling.
From emerging biotechnology organizations to leading global pharmaceutical companies, Opus provides specialized support at every stage of development.
Experienced Professionals. Targeted Expertise.
Our consultants bring 500+ years of industry experience and specialized knowledge across therapeutic areas, product types, and company sizes. Their experience ranges from Associate Director through executive leadership, providing clients with both strategic perspective and hands-on support.
Whether filling a critical resource need, supporting a specific project, or serving as an extension of an existing department, we align the right expertise with each organization’s unique needs.
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Advertising and Promotion
Medical Review & Medical Information
Regulatory Strategy
Chemistry, Manufacturing, and Controls
Labeling
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It’s not only what we do—it’s how we do it. We listen closely, build trusted relationships, and work collaboratively to understand each client’s priorities.
Our consultants integrate seamlessly into client teams, adapt quickly to different projects and working environments, and provide practical, solutions-oriented guidance. This flexible and hands-on approach allows us to deliver meaningful support while maintaining continuity and momentum throughout the project lifecycle.
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Every engagement is supported by a dedicated Client Service team. Through proactive communication, regular check-ins, and close alignment with both clients and Opus consultants, we help ensure each project runs smoothly and efficiently.
Why Opus Created MRL in Sync
Effective promotional review requires strong alignment among Medical, Regulatory, and Legal teams. It also requires opportunities for professionals to exchange experiences, examine emerging challenges, and learn from one another.
Opus developed Advancing Promotional Review: MRL in Sync to create a dedicated setting for these conversations. Through expert-led sessions, real-world case studies, panel discussions, and peer learning, the program brings industry professionals together to explore practical strategies for strengthening collaboration, improving decision-making, streamlining review processes, and supporting effective, compliant promotional communications.
Thought Leadership and Training
Opus is committed to advancing the industry through meaningful thought leadership, professional education, and opportunities for shared learning. In addition to MRL in Sync, Opus offers Promotional Review Fundamentals, a live, instructor-led virtual training program designed for pharmaceutical and biotechnology professionals involved in creating, reviewing, or approving promotional materials.
Led by experienced Opus consultants, this interactive two-day program combines foundational regulatory knowledge with practical guidance, real-world examples, and collaborative discussion. It can support individual professional development, team onboarding, refresher training, and stronger promotional review practices across an organization.
Work with opus
Looking for experienced support for your organization? Tell us more about your needs and discover how Opus can provide the specialized expertise and flexible support your team needs.
A member of our team will follow up to discuss your needs and how we may be able to support your organization.