One path from assay to released batch
Most development failures are handover failures. We keep discovery, translation, process and quality inside the same discipline so nothing is lost between them.
The bench and the plant are on speaking terms
Chemists, formulators and quality staff review the same candidate at the same gate. It keeps the unglamorous questions — yield, purity profile, filterability, pack stability — in the room while they can still be designed for.
Discovery & assay
Target validation and compound screening, with the stop criteria written before the first compound is made.
Translational science
Biomarkers and dose rationale established in-house, so the clinical question stays answerable.
Process development
Synthesis and formulation scaled in parallel with the biology, not after it.
Quality & release
Every batch released against documented specifications with full traceability.
Quality is a specification, not a slogan
The standards below are the ones we hold ourselves to on every lot we ship, and the ones an auditor can test us against.
- GMP manufacturing with independent batch certification
- Stability and dissolution testing on every released lot
- Elemental impurity and residual-solvent screening
- Full chain-of-identity records from starting material to pack-out
