Biosafety & Analytical
Excellence for Global Drug Development
From early preclinical development through commercialization, we deliver risk-mitigating testing solutions across monoclonal antibodies, recombinant proteins, viral vectors, vaccines, cell therapies, and emerging modalities.
As a pioneer in supporting China's first in vivo CAR-T IND approval, we balance operational agility with rigorous global compliance-ensuring your biologic is safe, effective, and ready for regulatory scrutiny at FDA, EMA, NMPA, and beyond.
150+
Regulatory Submissions
FDA/EMA/NMPA
Global Agency Coverage
24/7
Responsive Service Model
The Value We Provide
Trusted expertise that accelerates approval pathways worldwide, without
ever compromising on safety or quality.
Regulatory Compliance
First-mover advantage in complex regulatory landscapes
- First in China to support in vivo CAR-T IND approval
- 150+ successful regulatory submissions across FDA, EMA, NMPA
- Deep technical know-how to navigate evolving global requirements
Agility & Speed
Faster to market, never faster than safe
- Responsive service model spanning early preclinical through commercialization
- Balanced risk mitigation that optimizes development timelines
- Unwavering scientific integrity at every stage of the product lifecycle
End-to-End Partnership
Concept to compliance under one scientific roof
- Comprehensive testing across mAbs, viral vectors, vaccines, cell therapies
- Supporting emerging modalities and novel therapeutic approaches
- Single partner for biologics safety, analytical development, and regulatory readiness
Explore Our Services
Comprehensive biosafety and analytical capabilities tailored to your
program's unique requirements.
Biosafety Testing
Molecular & Genomic Services
Analytical Development & Validation