Strategic process development and external manufacturing oversight for every stage of development.
We bridge the gap between scientific innovation and reliable manufacturing, helping pharma and biotech companies navigate the path to regulatory approval.
Designing scalable, robust synthetic routes and managing optimization from gram-scale to 100+ kg to ensure reliable manufacturing.
Acting as your virtual site head for CDMO selection, contract negotiation, and seamless tech transfer from lab to GMP production.
De-risking your regulatory pathway with phase-appropriate CMC planning, risk assessment, and authoring support for IND/NDA filings.
Providing independent, rigorous technical evaluations to support investment decisions, licensing strategy, and M&A.
Led by Dr. Hyoung Lee, HIL CMC Consulting combines deep scientific insight with strategic leadership to support pharma and biotech programs from early development through IND/NDA milestones.
HIL CMC Consulting leverages 20+ years of pharmaceutical leadership to minimize risk and accelerate development.
Proven Leadership: Former leadership at global pharma organizations.
Deep Science: Hands-on mastery of complex small-molecule process chemistry.
Strategic Scope: Integrated oversight across R&D, Quality, and Regulatory affairs.
✓ Emerging Biotechs: Companies needing "Fractional CMC Leadership" to reach milestones without full-time overhead.
✓ Investors & VCs: Funds requiring technical due diligence on asset manufacturability.
✓ Established Pharma: Teams needing specialized expertise in complex process chemistry or supply chain expansion.
Partner with science-driven, real-world CMC expertise that moves molecules efficiently from concept to commercialization.
