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Bridging the gap between discovery and delivery
Bridging the gap between discovery and delivery
We partner with pharmaceutical and biotech innovators to design robust, phase-appropriate CMC strategies that withstand regulatory scrutiny. By combining deep scientific expertise with real-world operational leadership, we move programs efficiently from the lab to the patient.
Our Mission
Our Mission
To transform complex chemistry challenges into clear, executable strategies. We believe that successful drug development requires a balance of scientific rigor and commercial pragmatism – ensuring that what works in the flask also works in the factory.
Meet the Founder
Meet the Founder
Dr. Hyoung Lee – Founder & Principal Consultant
Dr. Hyoung Lee – Founder & Principal Consultant
With over 20 years of hands-on leadership in CMC development and process chemistry, Dr. Lee has guided small-molecule programs through every stage of the drug development lifecycle. He founded HIL CMC Consulting to provide emerging biotechs with the same caliber of technical leadership found in major pharmaceutical organizations without the full-time overhead.
A Dual Perspective: Operator & Strategist Dr. Lee brings a unique balance of "Big Pharma" rigor and investor-grade strategy. His background includes leadership tenures at Boehringer Ingelheim and Scynexis, where he managed small-molecule drug substance development, global supply chains and complex regulatory filings.
Currently, Dr. Lee holds a CMC Advisor position at Arrow Ventures, where he evaluates technical readiness and development strategy for portfolio assets. This dual role allows him to advise clients not only on how to make their drug but on how to position their data for successful investment and licensing.
Key Expertise:
Global Execution: Managed complex supply chains across the US, Europe, and Asia.
Investor Mindset: Deep experience in technical due diligence and asset valuation.
Regulatory Success: Extensive experience authoring and defending IND/NDA filings.
Why Innovators Partner With Us?
Why Innovators Partner With Us?
We don't just manage timelines; we understand the chemistry. Our strategies are grounded in real development experience, not just theory.
Operational Realism
We build plans for the real world. We prioritize pragmatic, execution-focused guidance over theoretical "slide deck" consulting.
Integrated Perspective
We connect the dots between Process Chemistry, Quality (QA), and Regulatory affairs to prevent costly gaps in your filing strategy.
Unbiased Advocacy
We are completely vendor-agnostic. Our only goal is to find the right manufacturing partner for your specific asset and budget
Firm Snapshot
Firm Snapshot
Founded:
Founded:
2025
Location:
Location:
Titusville, NJ (Serving clients globally)
Industry Focus:
Industry Focus:
Small Molecule Therapeutics (Pharma & Biotech)
Core Competencies
Core Competencies
Fractional CMC Leadership & Process Development
Fractional CMC Leadership & Process Development
Process & Development
Process & Development
Drug Substance Development
Chemical Process R&D
DoE & QbD–based Development
Tech Transfer & Readiness
Strategy & Regulatory
Strategy & Regulatory
CMC Strategy & Planning
IND/NDA Authoring
Risk Assessment & Mitigation
Fractional CMC Leadership
Manufacturing & Business
Manufacturing & Business
External Mfg (CDMO) Oversight
Vendor Management
Due Diligence (Investors)
Technical Assessment
Our Approach
Our Approach
We believe successful CMC development requires a balance of scientific rigor, regulatory awareness, and practical manufacturing execution. Our work is built on collaboration, transparency, and an understanding of what teams need to deliver results that last.
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