DRX2 Consulting, LLC

Where Regulatory
Science Meets
Business Strategy

●  Former FDA Scientist  ·  17 Years of Regulatory Authority Experience

Independent consulting in Toxicology, Regulatory Affairs, and Data Science — helping biotech, medical device, and pharmaceutical organizations navigate complex challenges with the perspective of someone who has worked on both sides of a regulatory submission.

Schedule a Consultation Explore Services
17
Years at US FDA
35+
Years STEM Experience
3
Core Disciplines
PhD
Biological Sciences
About

Science-First.
Strategically Grounded.

Principal Consultant, DRX2 Consulting LLC
Principal Consultant

DRX2 Consulting was founded on a simple conviction: that the most valuable regulatory guidance comes from someone who has sat across the table from the agencies your organization answers to. With 17 years as a scientist at the US FDA, I bring an insider's understanding of how regulators evaluate evidence, prioritize risk, and make decisions — not just what the regulations say, but how they are applied.

My practice sits at the intersection of toxicology, regulatory affairs, and data science — three disciplines that are increasingly inseparable in today's regulatory environment. Whether you are preparing a submission, responding to an agency request, building a safety data strategy, or navigating the rapidly evolving landscape of AI in regulated science, I bring both the technical depth and the strategic perspective to help you move forward with confidence.

I work with small and mid-size biotech and medical device companies, CROs and pharmaceutical organizations, and academic research institutions — any organization that needs to translate complex science into defensible, effective regulatory strategy.

Work With Me
FDA
US Food & Drug Administration
17 years as a regulatory scientist — direct experience in how the agency evaluates toxicological data, safety submissions, and compliance matters.
PhD
Doctorate in Biological Sciences
Graduate-level scientific foundation underpinning all toxicological assessment, safety evaluation, and data analysis work.
MBA
MBA — Strategic Management
Business and strategy training enabling translation of scientific challenges into actionable organizational decisions.
35+
35+ Years in STEM
35+ years of applied scientific experience across regulatory, industry, and data science domains — breadth that generalists cannot replicate.
Services

What DRX2 Offers

Integrated advisory services across the full spectrum of regulatory science — delivered with the perspective of someone who has operated inside the agencies your organization works with.

01
🔬

Toxicology Advisory

Expert toxicological review and strategy for drug, device, and biologic submissions. Risk assessment, safety data evaluation, and scientific justification for regulatory decisions — grounded in how FDA reviewers actually evaluate evidence.

Risk AssessmentSafety DataFDA SubmissionsExtractables & Leachables
02
📋

Regulatory Affairs Strategy

Strategic guidance through evolving regulatory requirements for pharma, biotech, and medical device organizations. From submission planning to agency responses, inspection readiness, and compliance gap analysis.

Submission StrategyFDA510(k) / PMACompliance
03
📊

Data Science Consulting

Scientific data strategy, analysis design, and interpretation for regulatory contexts — including emerging guidance on AI and machine learning in regulated life sciences, a critical and rapidly evolving area of focus.

Data StrategyAI/ML ReadinessStatistical ReviewGxP Data
04
🤖

AI Regulatory Readiness

Helping life sciences organizations prepare for FDA and EMA guidance on artificial intelligence in drug development, safety assessment, and device software — an emerging discipline where scientific and regulatory expertise are essential.

FDA AI GuidanceAI ValidationRisk FrameworkGxP AI
05
🏛️

Agency Interaction Support

Preparation and strategy for meetings, responses, and negotiations with regulatory agencies. Pre-submission meetings, written correspondence, and agency response support — with the advantage of understanding how agency scientists think.

Pre-Submission MeetingsAgency ResponseQ&A PrepNegotiation
Why DRX2

The Difference an Insider Makes

Most consultants advise on how to navigate regulatory agencies. DRX2 advises from the experience of having worked inside one for nearly two decades.

01
Former FDA — Not Just Familiar With FDA

17 years inside the agency means understanding not just what the regulations say, but how reviewers interpret them, what raises flags, and what builds confidence in a submission. That perspective is rare at the independent consultant level.

02
Three Disciplines, One Consultant

The convergence of toxicology, regulatory affairs, and data science in a single advisor eliminates coordination friction. Integrated thinking produces more coherent, efficient regulatory strategy than managing multiple specialists.

03
Science-Led Business Thinking

An MBA in Strategic Management means your regulatory challenges are addressed not just scientifically but in the context of your business goals — timelines, resources, and competitive positioning are part of every recommendation.

04
Ahead of the AI Regulatory Curve

FDA and EMA guidance on AI in drug development and device software is actively evolving right now. DRX2 helps organizations understand and prepare before these requirements become compliance obligations.

Contact

Start the Conversation

Whether you have a specific regulatory challenge or simply want to explore how DRX2 can support your organization, reach out. Initial consultations are confidential and without obligation.

🕑 Responses typically within one business day  ·  Eastern Time (EST)

All inquiries are treated with strict confidentiality.