Karen Rose, Ph.D. — Founder and Principal Consultant, Sage Ad Promo LLC
Karen Rose, Ph.D.
Founder & Principal Consultant
Pharma & Biotech · Regulatory Consulting

Building the Foundation for Compelling, Compliant Promotion

Everything your team needs to promote with confidence.

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 — from MLR infrastructure and launch strategy to promotional review and regulatory counsel.

Regulatory advice you can trust.


Sage Ad Promo was founded on the 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 experience, 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 regulatory review of promotional materials and advertising campaigns against FDA standards. Proactive guidance to prevent issues before they arise.

OPDP Standards MLR Support Digital/Social

Launch Strategy

Navigating the logistical complexities of a product launch, including building out your MLR infrastructure and governance, getting set up for FDA submissions, liaising with OPDP, and managing the advisory request process.

Launch Readiness Planning Infrastructure

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, compliant, 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 choose Sage?

Science-First Thinking

My Ph.D. in molecular biology and passion for science shapes how I approach every engagement. I dig into the mechanism of action, the preclinical and clinical data, the disease biology, and the competitive landscape, and use that understanding to sharpen messaging strategy, accelerate the review process, and help teams build promotion that is scientifically grounded, strategically differentiated, and built to hold up under scrutiny.

Executive-Level Strategy

My extensive experience in commercial regulatory affairs means I understand the business stakes, not just the compliance checklist. I know which battles are worth fighting, which risks are worth taking, and where the data genuinely supports pushing further than a more cautious reviewer might allow.

Agility Without Compromise

I work as an extension of your team — available when timelines are tight, responsive when questions arise, and invested in your program's success. You're never handed off to a junior reviewer; you get senior-level expertise with every interaction.

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 commercial regulatory infrastructure; I'd love to hear about it.

I typically respond within one business day.