HIL CMC Consulting
Bridging science and strategy to accelerate development success
CMC strategy, process development, and external manufacturing leadership for pharma and biotech innovators.
Embedded Files
WHAT WE DO
WHAT WE DO
Process Development & Scale-Up
Process Development & Scale-Up
Route design, optimization, and scale-up from grams to 100+ kg for efficient and reliable manufacturing.
CMC & Regulatory Strategy
CMC & Regulatory Strategy
Phase-appropriate CMC planning, risk assessment, and IND/NDA–enabling regulatory support.
External Manufacturing Leadership
External Manufacturing Leadership
CDMO selection, contracting, oversight, and seamless tech transfer from lab to pilot to GMP production.
Due Diligence & Technical Assessment
Due Diligence & Technical Assessment
Independent evaluation to support investment decisions, licensing strategy, and technical readiness.
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.
WHAT WE DO
WHAT WE DO
20+ years of hands-on small-molecule CMC and process chemistry experience
Leadership roles at Boehringer Ingelheim and other global organizations
ntegrated expertise across R&D, QA, regulatory affairs, and manufacturing
Proven success in CDMO selection, contracting, tech transfer, and lifecycle process development
WHO WE SERVE
WHO WE SERVE
✓ Emerging and mid-size pharma and biotech companies
✓ Investors and venture funds needing technical diligence on development programs
✓ Established organizations seeking external manufacturing leadership
Let’s accelerate your development program.
Let’s accelerate your development program.
Partner with science-driven, real-world CMC expertise that moves molecules efficiently from concept to commercialization.
Page updated
Google Sites
Report abuse