Pharma & Biotech · Regulatory Consulting

Where Science
Meets Strategic
Clarity.

Wise counsel. Confident compliance.

Sage Ad Promo brings executive-level FDA regulatory expertise directly to your advertising and promotion strategy, helping pharma and biotech brands move faster, stay compliant, and launch with confidence.

Karen Rose, Ph.D. Principal Consultant

Regulatory wisdom
built from the inside.


Sage Ad Promo was founded on a simple belief: that the most valuable regulatory guidance comes from someone who has sat at the table, navigating FDA expectations, bridging clinical science with commercial strategy, and turning complex requirements into clear, actionable direction.

With over 18 years in Regulatory Affairs, Advertising, Promotion & Labeling, I bring Ph.D-level scientific depth paired with the strategic fluency that only comes from years of real-world pharma experience. I've advised on product launches, guided promotional review teams, and helped brands find the path from insight to compliant market presence.

FDA Regulatory Ad/Promo Review Launch Strategy Biotech Pharma Ph.D Molecular Biology
Work With Me

Expert guidance
at every stage.

From early-stage strategy through launch and beyond; tailored regulatory consulting that moves at the speed your business demands.

Regulatory Ad/Promo Review

End-to-end review of promotional materials, digital content, and advertising campaigns against FDA standards. Proactive guidance to prevent issues before they arise, not after.

OPDP Standards MLR Support Digital/Social

Launch Strategy

Strategic regulatory input from pre-launch through market activation. I help align your commercial messaging with the science, ensuring your launch narrative is compelling, credible, and compliant.

Launch Readiness Messaging Strategy Claim Development

Marketing & Commercial Strategy

Bridging the gap between regulatory requirements and commercial ambition. I help marketing and medical affairs teams build campaigns that are scientifically grounded and strategically sharp.

Commercial Alignment HCP Marketing Preapproval Communications Accelerated Approval Payor/PIE Trial Recruitment Patient Materials SEO Corporate/Investor Comms

Training & Education

Custom regulatory training programs for marketing, medical affairs, and commercial teams. Practical, scenario-based learning that builds organizational confidence and reduces compliance risk.

Team Workshops SOP Development Custom Curriculum

Why clients choose
a different kind of counsel.

Science-First Thinking

A Ph.D in molecular biology isn't just a credential; it's a lens. I read the data, understand the mechanism, and translate scientific complexity into regulatory and commercial clarity that holds up under scrutiny.

Executive-Level Strategy

My extensive experience in commercial regulatory affairs means I understand the business stakes, not just the compliance checklist. Guidance that is both strategically sound and regulatory defensible.

Agility Without Compromise

As an independent consultant, I move at your pace: no agency overhead, no committee approvals; direct, experienced counsel available when your team needs it most, from early planning through launch.

Let's talk about
what you're building.

Whether you're preparing for a launch, navigating a complex promotional challenge, or building your team's regulatory fluency; I'd love to hear about it.

I typically respond within one business day.