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.

20+Years Experience
Ph.DMolecular Biology
FDAFDA & Industry Ad/Promo Experience
ExecExecutive Presence
AgileAgile & Creative
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 20 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.

01

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
02

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
03

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
04

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

Twenty years at the Director and Executive Director level 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.