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At HIL CMC Consulting, we deliver science-driven, execution-focused CMC guidance that enables efficient development, robust manufacturing, and regulatory success. We partner with pharmaceutical and biotech organizations to advance programs from early development through IND, NDA, and commercial readiness.
How We Support Your Development Goals
How We Support Your Development Goals
We provide strategic and technical leadership across the full CMC lifecycle, helping teams reduce risk, accelerate timelines, and make sound investment decisions.
Our Core Service Areas
Our Core Service Areas
Process Development & Scale-Up
Process Development & Scale-Up
Route development, optimization, troubleshooting, and scale-up from grams to 100+ kg for efficient and reliable manufacturing.
CMC & Regulatory Strategy
CMC & Regulatory Strategy
Phase-appropriate CMC planning, Module 3.2.S authoring, risk management, and IND/NDA–enabling strategy to ensure regulatory alignment and smooth submissions.
External Manufacturing & Due Diligence
External Manufacturing & Due Diligence
CDMO evaluation and oversight, tech transfer leadership, manufacturing readiness, and independent technical diligence for investors and licensing decisions.
Our Approach
Our Approach
We collaborate closely with clients to build practical, phase-appropriate plans grounded in data and real manufacturing realities—not theory. Our guidance reflects decades of experience across R&D, QA, regulatory affairs, and global external manufacturing.
Ready to discuss a project?
Ready to discuss a project?
Let’s explore how we can accelerate your molecule’s path from concept to commercial success.
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