FGK Representative Service GmbH acts as a legal representative for pharmaceutical and biotechnology companies which have no subsidiary within the EU and which submit regulatory applications to the European authorities.
The Clinical Trials Directive (2001/20/EC), implemented May 1, 2004, requires that a legal representative of the sponsor be established in the EU for all clinical trials conducted in the EU. This is why it is no longer possible for a company outside the EU to conduct a clinical study without an entity representing them in the EU.
Directive 2001/83/EC requires that for a marketing authorization application in the EU the applicant has to be established in the EU.
Regulation (EC) No 141/2000 requires that the sponsor seeking to obtain or having obtained the designation of a medicinal product as an orphan medicinal product from the EMEA must be established in the EU.
FGK Pharmacovigilance GmbH is a growing offspring of FGK Clinical Research GmbH, a full service Clinical Research Organisation headquartered in Munich, Germany. Besides being young, thriving and enticing to work for, FGK-PV is run by seasoned experts, who are bringing with them knowledge of authorities on both sides of the Atlantic, time-proven safety experience and a steady hand.
FGK PV offers:
Management of risk minimization activities, including assessment of effectiveness of these activities