From medicinal chemistry to commercial GMP supply — our services are structured around the way biotech and pharma partners actually work.
Engage us for a single study, a multi-year FTE team, or an end-to-end program from discovery to commercial.
Route scouting to commercial cGMP API and drug product.
Cell line to GMP bulk drug substance and fill-finish.
Medicinal chemistry, biology, DMPK, IND-enabling toxicology.
Phase I–III clinical operations, biometrics and regulatory affairs.
From first gram to commercial supply — we take your small-molecule program through process development, scale-up and cGMP manufacturing.
Sustainable, scalable routes with full process characterisation and QbD controls.
50 g to multi-ton cGMP API across four registered plants.
Tablets, capsules, injectables and suspensions — with clinical and commercial scale.
Full analytical support including ICH stability, method transfer and ICH Q3D.
Inbound and outbound tech transfers for clinical and commercial-stage molecules.
IND, NDA and ANDA CMC packages — FDA, EMA, PMDA and NMPA.
End-to-end biologics development and manufacturing for monoclonal antibodies, bispecifics, ADCs, fusion proteins and cell & gene therapies.
Integrated medicinal chemistry, biology, DMPK and preclinical toxicology. Single-vendor advantage — no tech transfer, shared data platform.
Phase I to III clinical operations across Asia-Pacific — from regulatory strategy through site monitoring, biometrics and pharmacovigilance.
Every partner program is different — we fit the engagement model to yours.
Single study or defined scope of work — ideal for specific CMC, chemistry or tox packages.
Dedicated integrated chemistry, biology or DMPK teams — a true extension of your R&D organisation.
End-to-end discovery-to-IND or IND-to-commercial partnership with a single governance framework.
Share the stage, modality and timeline — a Lianhe Life business development lead will respond within two business days.
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