Granzer Regulatory Consulting & Services GmbH
About us
Granzer Regulatory Consulting & Services offers support in all phases of drug and device development. From defining the right development strategy to submitting your marketing authorisation application, all the way through to approval and beyond.
We take great pride in supporting our clients with pioneering, innovative, and ambitious strategies. Our track record speaks for itself, as we have been first in the development of peptide-based vaccines, mRNA technologies, CAR-T therapies, CRISPR/Cas advancements, and the first marketing authorisation of a COVID-19 vaccine.
Address
Kistlerhofstrasse 172 C
81379 München
Germany
E-mail: fumagalli@granzer.biz
Phone: +49 89780689844
Internet: www.granzer.biz/
Contact person:
Dr. Stefan Blesse
E-mail: blesse@granzer.biz
Dr. Ornella Fumagalli
E-mail: fumagalli@granzer.biz
We offer
Global Regulatory Strategy
Agency Interactions
Regulatory Procedures
PRIME and Accelerated Approval Pathways
Drug Development
Orphan Development
Paediatric Development
Medical Devices and Combination Products
Borderline Products
Due Diligence
Project Management
Medical and Scientific Writing
Regulatory Operations
GMP Compliance, Storage & QP
HTA, Pricing & Reimbursement