CRO

In order to service our clients and offer the true "From molecule to market", we can offer CRO services through one of our valued partners. This truly makes GSI Pharmaceuticals the ideal partner of choice as we can offer full support throughout the entire life of your project, or just be an integral part of certain aspects.

Our partner company invested over one million Euros in building a modern Drug Evaluation Center in order to carry out studies of pharmaceutical bioequivalence and Stage I clinical studies. The center has an area of 1150 m2 with two distinct working sectors, a clinical unit and an analytical unit, respectively.

The clinical unit has 32 beds completely equipped, emergency and monitoring equipment and qualified personnel: pharmacologists, internal medicine and emergency specialists.

The analytical unit develops bioanalytical methods using the latest generation equipment by high-pressure liquid chromatography with UV detection, fluorescent and mass spectroscopy. There is an extensive list of analytical methods validated in compliance with the community legislation and FDA regulations. When requested, the bioanalytical determination laboratory can also develop methods for further analyses.

The center has its own laboratory of metabolite synthesis necessary for the bioequivalence studies.
The new bioequivalence center has its own quality insurance system during the clinical and analytical phases and the bioanalytical determination laboratory is certified Good Laboratory Practice (GLP) by the National Drug Agency. In order to develop bioequivalence studies, the facility has a listing with over 600 healthy volunteers registered in our data base.

Please contact us to see how we can help move your project along the complex road to market.

Need more information? Feel free to contact us to get the information you need.