Your official, independent legal entity interfacing with national competent authorities
Direct physical headquarters in Skรฆvinge, Denmark[cite: 1]. Direct liaison with the Danish Medicines Agency, EUDAMED actor registration, post-market vigilance, and technical file custody.
Full post-Brexit compliance for Great Britain. Device and IVD registration with the MHRA, UKCA regulatory assistance, and local Great Britain inquiries coordination.
Compliance with Swiss MedDO and IvDO legislation. Dedicated communications with Swissmedic, mandate agreements, and SWISSDAMED notification pathways.
Operational presence in Illinois, USA[cite: 1]. Annual establishment registration, device listings, 510(k) pathway support, and emergency FDA inspection liaison.
Designated Australian sponsor registering devices in the Australian Register of Therapeutic Goods (ARTG) and managing TGA regulatory reporting.
National Medical Products Administration (NMPA) designated local representation, testing coordination, and product license filing across mainland China.
Direct regulatory access and product dossier approvals across high-growth international healthcare markets
Technical Documentation, ISO 13485 QMS, and European Legal Importer infrastructure
Technical Documentation per Annex II & III, GSPR checklists, Post-Market Clinical Follow-up (PMCF), and Notified Body audit support.
Quality Management System implementation, gap analyses, mock audits, and Manufacturing License filings.
Article 13 MDR compliance, Spanish customs entry assistance (AEMPS), and CE certification verification.
Free Sales Certificates (FSC), General Product Safety Regulation (GPSR), and EU Cosmetics Responsible Person services.
Connect directly with our European regulatory affairs specialists
๐ Global Headquarters (Denmark):
Kaj Sommers Vej 6, 3320 Skรฆvinge, Denmark[cite: 1]
CVR: 45000524 ย |ย SRN: DK-AR-000043850[cite: 1]
๐ฉ๐ฐ Denmark Office: +45 91632811[cite: 1]
๐ฎ๐ณ India Office: +91 9061033526, +91 9349208199[cite: 1]
๐บ๐ธ USA Office (Illinois): +1(630) 3468914[cite: 1]
๐ฆ๐ช Dubai (UAE) Office: +971 526027286[cite: 1]