Analytical Services
COMPLETE PLATFORM – ANSM APPROVAL FOR CLINICAL / COMMERCIAL QC
METHOD DEVELOPMENT & VALIDATION
Stability indicating methods, Forced degradation studies – QbD – Extractables and Leachables -Validation – Analytical transfer
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, 25°C/40%RH, 40°C/NMT 25%RH, cycling conditions, 2-8°C, -20°C
Real time use (in-use)
Chromatography: HPLC, UPLC, UV, Fluorescence, DAD, GC-FID, API, excipient content, degradation product, residual solvents
Water determination: volumetric titration, LOD, TGA
Specific tests for tablets, inhaled products (ex dissolution, NGI, HIAC, Spay Pattern, Plume geometry)
DEVELOPMENT SUPPORT
PHYSICAL PROPERTIES CARACTERISATION :
Compatibility studies, prediction of raw material behaviour (humidity, temperature, solvent)
PHARMACEUTICAL DEVELOPMENT STUDIES
CTD P2 section + respiratory forms
DEVICE DEVELOPMENT
inhalation device, plasters, syringues, physical characterisation
