Analytical Services
COMPLETE PLATFORM – ANSM APPROVAL FOR CLINICAL / COMMERCIAL QC
Physical Properties Characterisation
Compatibility studies and predicting of raw material behaviour
Solid Dosage Forms
Respiratory Forms
Medical Devices
METHOD DEVELOPMENT
Bibliography (Pharmacopoeia, Publications) – Method stability indicating if needed
Forced degradation – Extractables and Leachables – Light cabinet
Validation – Analytical transfer – Pre-stability study
QUALITY CONTROL for clinical / commercial batches
Stability at all conditions : 25°C/60%RH – 30°C/65%RH – 30°C/75%RH – 40°C/75%RH – 30°C/75%RH – 2-8°C – Low humidity – cycling conditions
Real time use (in-use)
Chromatography: HPLC, UPLC, UV, Fluorescent, DAD
