Granzer Regulatory Consulting Information

At Granzer Regulatory Consulting & Services, we facilitate the life of our customers by helping to provide strategic and operational input into drug and device development and all elements of regulatory affairs including a sound regulatory strategy – We start by defining the right time for a 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 interactions including dossier preparation and full regulatory submissions. We track applications, facilitate, prepare and moderate authority meetings in national, mutual recognition, decentralised and centralised procedures including arbitrations and referrals. We provide the right support for filings and contacts with the FDA.