Regulatory, scientific, innovation, and organizational guidance for leaders navigating their hardest decisions — grounded in decades of operating experience.
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Founder-led. Grounded in decades of operating experience across regulatory affairs, R&D, innovation, commercial, and digital transformation in global healthcare organizations.
Senior Advisory. Grounded in Experience.
Deep expertise navigating FDA and global regulatory frameworks — from pre-IND through lifecycle, across drugs, devices, supplements, and consumer health.
Science-to-market strategy across complex product categories — product concepts, target product profiles, evidence requirements, and innovation portfolio prioritization.
Transformation experience inside global healthcare organizations — operating model design, AI-readiness, and cross-functional digital initiatives at scale.
Who We Work With
RGM works with life sciences and consumer health companies that need experienced regulatory, scientific, and strategic judgment at important decision points.
Setting product, market, and category direction.
Strengthening strategy, FDA engagement, and team capability.
Shaping claims, evidence, and launch readiness.
Assessing regulatory and scientific risk in transactions.
What They're Navigating
Entering the U.S. market
Advancing product development programs
Preparing for FDA interactions
Evaluating claims and evidence
Launching dietary supplement or consumer health products
Modernizing regulatory or R&D organizations
Assessing regulatory and scientific risk in transactions
We work across consumer healthcare, biopharma, dietary supplements, medical devices, women's health, OTC and non-prescription products, and adjacent categories — including products that do not fit neatly into one box.
Services
RGM's services are organized around four areas of client need.
Insight on the product, the regulatory pathway, FDA engagement, market entry, and launch.
→Insight on what can be credibly claimed, supported, communicated, and defended.
→Practical guidance on how regulatory, R&D, and scientific work is organized, led, modernized, and connected to the business.
→Trend analysis, FDA precedent insight, opportunity assessment, and transaction support.
→What Makes RGM Different
RGM is founder-led. The work is shaped by direct operating experience inside large, complex life sciences and consumer healthcare organizations — not by advisory experience alone.
~170
Colleagues in a global regulatory organization built and led by the founder
2,000+
Scientists represented in R&D organizations led globally
3,000+
Marketing authorizations managed in transaction diligence and integration
Her experience extends well beyond regulatory affairs — spanning innovation strategy, new product development, global R&D operations, cross-functional digital initiatives, and AI-readiness programs. That breadth — regulatory, R&D, commercial innovation, and digital — is unusual in a single advisor and shapes how RGM looks at every client question.
RGM is particularly valuable in areas where the answer is not obvious: Rx-to-OTC switch, ACNU, dietary supplements, women's health, consumer health innovation, claims substantiation, U.S. market entry, AI-enabled regulatory transformation, and products that sit between regulatory categories.
How We Engage
U.S. market-entry assessment
Claim substantiation review
FDA meeting strategy
Product-positioning assessment
Investor diligence review
Fractional regulatory or scientific leadership
Regulatory or R&D organization diagnostics
AI-readiness programs
Leadership capability work
Training for regulatory and scientific teams
For larger or geographically distributed engagements, RGM works with a trusted network of senior consultants — assembled to fit the specific demands of the project. Clients always work directly with the founder, who leads the engagement and ensures the integrity of the work.
The Founder
Founder & Principal
A global regulatory, scientific, and transformation executive with decades of leadership experience inside major life sciences and consumer healthcare organizations — including Sanofi Consumer Healthcare, Sanofi R&D North America, Reckitt, and Pfizer Nutrition.
She is also a member of the faculty at Rutgers University, teaching Fundamentals of Regulatory Affairs in the Master of Science and Master of Business and Science programs.
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