At Granzer Regulatory Consulting & Services, we make our customers’ life easy by providing strategic and operational input for drug and device development and all elements of regulatory affairs, including a sound regulatory strategy. We start by defining the right time for the first contact with the relevant regulatory authorities in Europe and the United States. We facilitate the first contacts, help prepare briefing packages for authority meetings and accompany all phases of interaction, including dossier preparation and full regulatory submissions. We track applications, facilitate, prepare and moderate authority meetings in national, mutual recognition including arbitrations, referrals and centralized procedures. We provide the right support for filings and contacts with the FDA. www.granzer.biz FGK Clinical Research GmbH Heimeranstrasse 35 80339 Munich Germany T | +49 (0) 89 893 119-0 F | +49 (0) 89 893 119-20 www.fgk-cro.com info@fgk-cro.com