Our integrated capabilities work together to turn complex challenges into reliable solutions — from concept to commercial supply.
01
Overseas Business
A dedicated project lead serves as your single point of contact from feasibility through production. We provide milestone tracking, proactive risk management, and clear communication through close coordination with cross-functional groups at every stage.
02
Research & Development
We engage partners in the early stage, developing and optimizing synthetic routes, establishing analytical methods, and building the technical documentation needed for regulatory filings. Every process we develop is designed from the outset to scale from lab bench to commercial production without compromise.
03
cGMP Manufacturing
Two GMP-certified sites. Regulatory clearances from the FDA, PMDA, EDQM, and ANVISA. Dedicated facilities for both clinical-phase and commercial-scale API production.
01
CDMO Business: Aligned to Deliver
The Overseas Business team serves as the primary interface with global clients.
Project managers in this group are responsible for translating client expectations into
executable plans—aligning scope, timelines, communication cadence, and change management.
They ensure that client feedback, evolving priorities,
and commercial considerations are reflected accurately throughout the project lifecycle.
Dedicated project leads
A single point of contact throughout the project lifecycle.
Timeline & Milestone Tracking
Clear visibility on progress and upcoming milestones.
One-stop Communication
Fast and transparent communication for better collaboration.
02
R&D: Technical Ownership and Risk Mitigation
R&D process & analytical leads work closely with customers to drive development activities forward.
Their role goes beyond tracking milestones; they actively identify technical risks,
manage troubleshooting pathways, and coordinate rapid decision-making when challenges
arise—whether related to route optimization, impurity control, scalability, or method readiness.
Process development & optimization
Optimized processes designed for efficiency, quality, and scalability.
Analytical method development
Robust analytical methods to ensure consistent quality and performance.
Tech Transfer
Scale Up oriented, On site tech transfer
03
Yuhan Chemical Inc.: Execution Excellence Assured
Project managers at Yuhan Chemical, a 100% wholly owned subsidiary of Yuhan
Corporation oversee manufacturing readiness and GMP execution.
They coordinate campaign planning, raw material readiness, capacity alignment,
and compliance activities, while maintaining close visibility on on‑time,
right‑first‑time manufacturing performance.
Any deviation or execution risk is promptly escalated and
addressed through cross‑functional collaboration.
Two cGMP-certified sites
Reliable production across two cGMP-certified manufacturing sites.
Multi-regulator approved FDA, PMDA, ANVISA, EDQM
Proven Track Record with Leading Global Regulatory Authorities FDA, PMDA, ANVISA, EDQM
Pilot to commercial scale manufacturing
Seamless scale-up from pilot production to commercial manufacturing.