Lianhe Life
Drug product manufacturing, medicinal chemistry and custom synthesis.
What they do
- Discovery & research
- Preclinical
- Development & CMC
- Manufacturing
- Testing & analysis
From their website
Services
- Route scouting & optimisation (opens in a new tab)
- cGMP API campaigns (opens in a new tab)
- Drug product formulation (opens in a new tab)
- Method development & validation (opens in a new tab)
- Tech transfer in or out (opens in a new tab)
- CMC regulatory support (opens in a new tab)
- Stable cell line development (opens in a new tab)
- Upstream and downstream process development (opens in a new tab)
- Bulk drug substance GMP manufacturing (opens in a new tab)
- In vitro ADMET and in vivo DMPK (opens in a new tab)
- Disease-specific pharmacology models (opens in a new tab)
- GLP IND-enabling toxicology (opens in a new tab)
- Regulatory strategy and submission support (opens in a new tab)
- Fee-for-Service (opens in a new tab)
- FTE Team (opens in a new tab)
- Integrated Program (opens in a new tab)
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Index
Technology
Quality & certifications
- FDA inspected (opens in a new tab)
- EU GMP (opens in a new tab)
- PMDA accredited (opens in a new tab)
- NMPA approved (opens in a new tab)
- ICH Q7/Q10 (opens in a new tab)
- ICH Q11 (opens in a new tab)
- AAALAC accreditation reported (opens in a new tab)
- GLP (opens in a new tab)
- ISO 9001 (opens in a new tab)
- ISO 14001 (opens in a new tab)