FGK Representative Service was set up to act as your legal representative within the European Union as stipulated by the EU directive 2001/20/EC, which is now required by all European regulatory authorities. In addition, to meet similar requirements of Swiss regulatory authorities and Swiss insurance companies, we established our own affiliated FGK Representative Service AG in Zug, Switzerland.
FGK Representative Service enables regulatory submission of your clinical trial and represents you in a range of application processes – marketing authorization, orphan drug designation, etc. Some of our clients with European establishments can obviously do this for themselves; others want to avoid that liability.
We operate in all member states of the European Union and Switzerland, and hold all appropriate insurances. We have been audited by regulatory authorities with the best of outcome. We are fast and efficient, flexible and easy to contract with – all at a reasonable price.
Should you like to conduct a clinical trial, file a marketing authorization or obtain an orphan medicinal product designation in Europe, please visit www.fgk-rs.com for more information.