Research & Development

Main GalenicalLaboratoriesEquipments

Rotary tablet press equipped with 8 stations Tablet pan coater (lab and pilot scale) Hard gelatin capsules filling machine Lab scale (homogenizer vacuum processing unit) Multi-purpose lab equipment with grinders,

kneader, homogenizer, mixers Angle of static repose equipment Laser diffraction particle size analyser Microscope with digital photo camera Hardness and friability tester Viscosimeter and turbidimeter

Research & Development

Main AnalyticalLaboratoriesEquipments

High Pressure Liquid Chromatography (HPLC) with the following detectors:

- Variable wavelength - Diode array - Fluorescence - Refractive index - ELSD - MS (single – quadrupole)

Inductively Coupled Plasma Optical Emission Spectometry (ICP-OES) Atomic Absorption Spectrometry (AAS) Dissolution apparatus

Research & Development

Galenicaland AnalyticalDevelopment

First assessment of feasibility based on our experience in formulations Characterisation, evaluation, choice and

assessment of raw materials Preformulation and formulation studies Reformulations of products in liquid, semi-solid

and solid forms Development and validation of analytical

methods (ICH) Microbiological analysis and challenge tests Pilot, industrial batches and clinical batches Stress tests and ICH stability studies

NTA 2B, CTD-Module 3 Quality Chemical-pharma- ceutical and biological Documentation for activesubstances and biological medicinal products.NTA 2B, CTD-Module2.3. Quality OverallSummary

Research & Development

Galenicaland AnalyticalDevelopment

Literature search in databases Specific toxicological and pharmacological studies

NTA 2B, CTD-Module 4 Nonclinical Study ReportsNTA 2B, CTD-Module 2.4 Nonclinical OverviewNTA 2B, CTD-Module 2.6 Nonclinical Summaries