Pharmaceuticals Programme capabilities

Quality assurance of all dosage forms

• physical and chemical testing
• microbiological testing including sterility
• microbiological assay

General analysis

• LC with UV incl. diode array, Fluorescence, MS/MS detection
• GC with FID, NPD, ECD, MS(EI & CI)
• Spectrophotometry/spectroscopy incl. FTIR, UV-Vis, NMR
• microbiological assay

Product development

• in vitro establishment of antimicrobial activity and testing of antibiotic substances against clinical isolates
• analytical development and validation
• stability testing

Product comparisons

• dissolution profiles
• bioequivalence studies

Stability studies

• carried out to ICH guidelines
• stability ovens on site
• integrated assay reporting

Regulatory consultation assessments of:

• manufacturing process and control
• quality control
• stability data
• bioavailability/bioequivalence studies to develop applications to market medicines.