Granzer Regulatory Consulting & Services GmbH

Granzer Regulatory Consulting & Services offers support in all phases of drug and device development. From defining the right development strategy to submitting a marketing authorisation application, all the way through to approval and beyond, as a one-stop-shop for our clients.

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.

We cover all types of therapies and diagnostics (small molecules, biologics, cell and gene therapies, drug-devices and many more) in all indications. This includes paediatric as well as orphan development, PRIME and Accelerated Approval pathways.

Delivering on this promise for more than 20 years, we have supported more than one thousand clients in Europe, North America, Japan, Australia, and Asia.

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
• HTA, Pricing & Reimbursement