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International

In addition to our domestic expertise in FDA advocacy, guidance and support, we have significant experience in dealing with international regulatory agencies including: 

• The European Agency for the Evaluation of Medicines (EMEA) Committee of Proprietary Medicinal Products, the analogous agency to FDA's Center for Drug Evaluation and Research (CDER) 

• Germany's Federal Institute for Drugs and Medical Devices (BfArM)

• Greece's National Organization for Medicines (EOF)

• The Collaboration Agreement of Drug Regulatory Authorities in European Union Associated Countries (CADREAC)