Our team consists of highly-trained professionals from the pharmaceutical industry and pharmaceutical research with significant experience in big pharma. The team includes experienced formulators and scientists in analytical science and material characterisation. The clinical supply and manufacturing operations are conducted under a validated and approved quality system. Our QS has been approved by local regulatory agency and audited by national and international organisations. AMS’s Qualified Person has twenty years of experience in generic companies and big pharma organisation with wide exposure to clinical and commercial supplies.
Moreover, AMS has a strategic cooperation with the Research Center for Pharmaceutical Engineering RCPE (www.rcpe.at) which are experts in the field of science-based product and process development. Together with RCPE, AMS provides access to rational design of formulations for complex products (API-polymer compounds, co-crystals, salts, amorphous forms, etc.) based on material-science principles small-scale screening with advanced analytic tools state-of-the-art materials characterization process design in the field of hot melt extrusion and spray drying model-based process scale-up and process transfer.
Moreover, AMS holds a GMP license in all of the above mentioned manufacturing methods.