GMIS has established key partnerships within Germany to offer services for all the stages of the EU market access process. This includes services for products such as medical devices, diagnostics, biotech, health IT, and pharmaceuticals.
EU Regulatory Services
Regulatory Compliance Strategy
Technical Documentation Compilation & Update
Quality Management System (QMS) Setup
Post-Market Surveillance (PMS)
Unique Device Identification (UDI) System
Notified Body Selection & Coordination
Person Responsible for Regulatory Compliance (PRRC)
Gap Analysis
Market Access & Reimbursement
Market Assessment
Reimbursement Strategies
DRG Application
NUB Application
OPS Application
PZN-Registration
Application for the Medical Aid Catalogue
BVL Registration
Early Benefit Assessment
Public Affairs & Relations
Health Economics Models
Distribution and Warehousing
ZE Application
