Drug Development Strategy Consulting
Avoid the Early-Stage Mistakes That Cost Biotechs Millions
Most drug development failures are strategic, not scientific. We help biotech startups and researchers build executable development plans — from discovery through IND filing — so you invest in the right studies at the right time.
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Years in Pharma
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Drug Programs
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Regulatory Jurisdictions
FDA · EMA · International
PhD
Education
Washington University
Who We Help
Find Your Path Forward
We work with teams at different stages. Select the one that fits you best.
What We Do
Services Built Around Your Stage
Our Process
How We Work Together
Every engagement follows a clear, proven process — no surprises, no wasted time.
Discovery Call
A free 30-minute conversation to understand your science, your goals, and your constraints. We listen before we recommend.
30 minutes · FreeLandscape & Gap Analysis
We study your competitive landscape, regulatory precedents, and existing data. We identify what you have, what you need, and what you can skip.
1-2 weeksStrategy Design & Delivery
We build your development plan: milestones, timelines, go/no-go criteria, regulatory pathway, and budget framework. Delivered as an actionable document, not a theoretical deck.
2-4 weeksOngoing Advisory
As you execute, we stay available. Data changes, landscapes shift, regulatory feedback arrives. We help you adapt the strategy in real time.
Optional retainerClient Story
From Lab Bench to IND Filing in 18 Months
An early-stage oncology biotech had promising preclinical data but no regulatory strategy. Their investors were asking for a clear development plan before committing Series A funding.
18months
Discovery → IND
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Clinical holds
$24M
Series A secured
100%
On schedule
Why EPD Consulting
Your Drug Development Partner, Not Just a Consultant
At large firms, the partner sells the work and junior associates deliver it. At EPD, Dr. Rodriguez is the one doing the work. Every engagement is boutique, personalized, and grounded in 20+ years of hands-on pharmaceutical development.
You Get the Senior Expert
Dr. Rodriguez works directly on your project — no handoff to junior staff.
Executable, Not Theoretical
Strategies you can actually implement with your resources, not 200-page shelf documents.
FDA + EMA Expertise
Based in Frankfurt with deep experience across US, European, and international regulatory pathways.
Startup-Friendly
We understand limited budgets and tight timelines. Flexible engagement models from project-based to retainer.
“I help researchers transform their scientific innovations into lifesaving therapies. My goal is to make the path from bench to bedside clearer, faster, and more achievable — especially for those just starting their journey.”
Dr. Marisela Rodriguez
Founder & Principal Consultant, EPD Consulting
Ready to Build Your Development Strategy?
Book a complimentary 30-minute strategy call. We'll discuss your project and tell you honestly whether we can help.