Regulatory Affairs (RA)
Navigate Global Regulations with Confidence
Pelican MedTech provides comprehensive regulatory services, from strategy development to market approval.
Support for CE Marking (EU MDR/IVDR), FDA 510(k), PMA, and De Novo submissions.
Preparation of RA strategies for global markets.
Preparation and submission of regulatory dossiers for North America, APAC, LATAM, Russia, and CIS.
Pre-submission consultations and regulatory pathway analysis.
Labeling and Instructions for Use (IFU) review.
Post-market surveillance and incident reporting.
Assistance with selecting Notified Bodies and European Representatives.
Internal Audits.
Solutions how to manage regulation processes in multiple counties.
Our experts
act as an extension of your regulatory team, ensuring your innovations reach
patients safely and compliantly.