Development
Analytical development
Method development and validation built around ICH guidelines and pharmacopeial expectations, designed to be transferable to a QC laboratory.
Methods built for the regulated market
An analytical method is only as useful as the QC laboratory that has to run it every batch. We build stability-indicating methods with reproducibility, robustness and transfer in mind — from the first feasibility experiment to validated, locked-down release and stability methods.
- Method development for assay, related substances and dissolution
- Method validation per ICH Q2(R1)
- Forced degradation studies
- Method transfer protocols and reports
- Cleaning method development and validation
- Reference standard qualification
Equipment overview[A CONFIRMAR]
- HPLC — quantity & vendor
- UPLC — quantity & vendor
- Gas chromatography
- Dissolution apparatus
- Particle size analyser
- UV-Vis spectrophotometer
- DSC / TGA
Detail to be confirmed against the actual instrument inventory (brief §10.4).
Method transfer in scope?
We routinely receive methods from sponsor laboratories and validate them under our quality system, or rebuild them to a stability-indicating standard if the gaps justify it.