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.
We provide our services to young biotech companies and established global pharmaceutical firms as well as small and medium sized companies in the areas of:
