We have engaged in the whole lifecycle of chemical entities, including ROS screening, process development & optimization, scale-up, registration & validation campaign through to commercial supply. With the concept of “Develop for Production” and “Lab to Plant by the same team”, we can ensure the timely project transfer from lab to industry with 100% success rate and eco-friendly.
Langhua Pharma, as our manufacturing site, has passed FDA, WHO, EDQM, ANVISA and CFDA’s inspections, has the ability to ensure the risk-free GMP compliance to support customer NDA filing. Moreover, Langhua excellent EHS system passed PSCI and big pharma’s inspection as well. Plenty CDMO cases have been completed in Langhua site.
We respect customers’ intellectual property, set up the procedure to protect customer’s confidential information. Think of CDMO, Think of Nuobai Pharm.
Raw Material Supply
• Supplier qualification: On-site audit • QESH expert to upgrade supplier EHS/GMP level • In-house production as backup plan
EHS
• EHS management system implemented • Audited by US and EU big pharma customers • Passed PSCI Inspection • Eco Vadis Evaluation (Score 52, silver) • Safety Lab to ensure Risk-Free in scaling-up
GMP
• Robust GMP quality System • NMPA / FDA/EDQM / WHO / PMDA / ANVISA approval
CDMO "One-stop" Solution
Supplier Management (GMP/EHS)
Quality & EHS by Design
Innovation for commercialization
Full technical understading
Lab to Plant by Same Team
Cost-effective robust process design
IP Respect & Protection
Material Availability-Supported by Global sourcing
