Overview

With a high-income economy, and sharing international borders with some of the Europe’s lucrative trade markets, the landlocked country – the Grand Duchy of Luxembourg boasts a good fortune for medicine and medical device manufacturers’ investments. The Ministry of Health, Luxembourg officially oversees the registrations and market access into the region. However, for foreign manufacturers without an authorized representative, market entry might seem challenging.

Freyr with the capabilities to hold a strong in-country representation, assists foreign manufacturers to keep abreast with the Luxembourg Regulatory regime for successful compliance and timely approvals as well. Freyr’s end-to-end Regulatory affairs consulting for Luxembourg span across:

  • Medical Devices
  • Pharmaceuticals / Drugs
  • Cosmetics and Food Supplements
  • Biologics

Freyr Offerings

  • Strategic Regulatory Consulting
  • Strategic business development focusing on the European market
  • Regulatory roadmap for market access
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • End-to-end operational support
  • Dossier preparation, review and management
  • Regulatory Submissions
  • Market assessments
  • In-country representation 

Freyr Advantages

  • Expert Regulatory team with proven global RA expertise
  • Proactive and Collaborative approach
  • Quick turnarounds and faster time-to-market
  • Keeping abreast with region-specific legislation and Regulatory guidelines