Global Regulatory Assistance & In-Country Representation Inquiries
Whether you require European Authorized Representation (EU REP), UK Responsible Person, Swiss representation, US FDA Agent support, or multi-country device approvals, our international specialists are ready to assist.
Fill out the details below and an RA specialist will respond within 24 hours
European Med Services & Regulatory Affairs Headquarters
Bureau Medica Intercert DK
Kaj Sommers Vej 6,
3320 Skævinge, Denmark
Official RA Inquiries: info@bureaumedica.com
Web Portal: www.bureaumedica.com
Denmark HQ (CET): Monday – Friday, 09:00 – 17:00
Global Coordination: 24/7 emergency vigilance intake for designated authorized representation clients.
Key insights regarding European in-country representation and regulatory engagement
Upon completion of the preliminary technical documentation review and mutual representation mandate agreement, we can issue the formal European Representative mandate within 3 to 5 business days.
Yes. As an authorized EU REP registered under SRN DK-AR-000043850, we verify and validate non-EU manufacturer actor registrations on EUDAMED and assist with device UDI data attributes.
Strictly yes. We maintain independent regulatory separation from commercial importers and distributors, safeguarding your proprietary design files and manufacturing secrets under Danish non-disclosure law.