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was founded in
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order to meet legal requirements of sponsor companies which do not
have a subsidiary within the European Union (EU) and Switzerland, for
the purpose of performing clinical research projects in the EU. Such a
representative, known as a “legal representative” for clinical drug trials
and “authorized representative” for medical device trials, fulfills the obli-
gation that the drug and the medical device companies must be
established or represented in the EU.
We can represent you as your “legal representative” in all member
states of the European Union for all your drug and medical device trials
to enable submission of your regulatory applications to the European
authorities and ethics committees.
We offer support for you and your contracted local CROs who might
not be able or experienced to provide legal representation services.
A group of highly experienced regulatory experts at FGK Representative
Service GmbH will provide you with competent, quick and cost-efficient
legal representation services.
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FGK Representative
Service GmbH
Heimeranstrasse 35
80339 Munich
Germany
T | +49 (0) 89 893 119-22
F | +49 (0) 89 893 119-20
www.fgk-rs.com
info@fgk-rs.com |
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