Greetings from
Freyr Denmark
For many years, Denmark has been a promising location offering good scope for medicine and medical devices investments. To obtain the market access, manufacturers must obtain approvals from The Danish Health and Medicines Authority (DHMA), an agency oversees the registrations and licenses across the region. Right from holding an authorized representative anywhere from the EU region, foreign entrants must go through many complex Regulatory procedural challenges, failing in any of which might affect compliance efforts.
Freyr, as a specialized global Regulatory partner, provides Regulatory affairs consulting across Denmark enabling manufactures be compliant for in-time product registrations and market authorizations in the region. Freyr’s end-to-end Regulatory capabilities for Denmark span across:
Industries We Serve in Denmark
Denmark is highly regarded for its thriving pharmaceutical market. All medicinal products to be marketed in the country must be approved by the Danish Medicines Agency before marketing them locally. As per the Directive 2001/83/EC, any new medicinal product shall be registered through a Marketing Authorization Application (MAA) following certain procedures:
Freyr Offerings
- Strategic Regulatory Consulting
- 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
- Product Information Leaflet (PIL)
- 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