Greetings from
Freyr Ireland
With a booming economy and growing investment opportunities in life sciences sector, the Republic of Ireland stands a good bet for foreign medicinal and medical devices manufacturers to invest in the region. To enter the Irish market, manufacturers must obtain market authorizations from the Health Products Regulatory Authority (HPRA). Though the market seems to be lucrative, the challenge arises with navigating the complex Irish Regulatory regime for successful registrations, licensing and compliance.
To assist manufacturers with an updated and strategical roadmap for the region, Freyr offers end-to-end Regulatory affairs services to obtain the Irish market access successfully. Freyr’s end-to-end Regulatory affairs consulting in Ireland span across:
Industries We Serve in Ireland
Despite a moderate growth value, consistent demand for medicinal products has made Ireland a viable market for drug and biological products. Before marketing medicinal products in the country, manufacturers must obtain an approval from the Health Products Regulatory Authority (HPRA) of Ireland by submitting a Marketing Authorization Application (MAA). 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 Affairs & Regulatory intelligence
- Dossier management
- eCTD conversions
- Regulatory Submissions
- Local labeling management support
- Pharmacovigilance
- Regional level support for CP/DCP/MRP procedures
- GMP audits
- Readability Testing (RUT)
- 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