About us

THE IRME ADVANTAGE

The IRME Advantage at a Glance

Service Capability
IRME
Typical Competitor
ISO 13485:2016 Certified Operations
ISO 13485:2016 Certified Operations
SFDA-Licensed Authorized Representative
SFDA-Licensed Authorized Representative
Dedicated Project Manager per Client
Dedicated Project Manager per Client
Full-Spectrum: Medical Devices + Pharma + Food
Full-Spectrum: Medical Devices + Pharma + Food
15+ Years Hands-On SFDA Experience
15+ Years Hands-On SFDA Experience
Partial
Serving 50+ Countries Globally
Serving 50+ Countries Globally
Partial
Master Partnership / Retainer Program
Master Partnership / Retainer Program
Partial
Post-Market Surveillance & PMS Support
Post-Market Surveillance & PMS Support
UDI / Saudi-DI Registration Capability
UDI / Saudi-DI Registration Capability
eCTD Pharmaceutical Submission Expertise
eCTD Pharmaceutical Submission Expertise