Novel compound? Novel method.
For compounds outside our standing catalogue, we develop, optimise, and validate the analytical method — then hand you the full ICH Q2(R1) validation dossier ready for regulatory submission.
What is measured.
Every attribute is quoted, run, and reported against the same reference method. Add-ons run from the same submission.
Scoping & feasibility
Compound review, matrix assessment, and a written scope of work with milestones.
Method development
Column screening, gradient optimisation, and detector selection. Iterated to fit-for-purpose.
Validation
Specificity, linearity, accuracy, precision, LOD/LOQ, robustness, and range.
Transfer & training
Method transfer package for your internal lab or a partner CRO, with signatory training.
MA-S05-DEV-01
Abbreviated method sheet. Full validated method (linearity, robustness, system suitability) available under NDA.
A certificate you can hand to a regulator.
- Validated SOP with system-suitability criteria
- Full ICH Q2(R1) validation report (submission-ready)
- Raw data package: chromatograms, spectra, integration logs
- Method transfer package with acceptance criteria
- IP-clean — validated method is yours to run anywhere