Ireland

MedWisdom LifeScience understands the burgeoning opportunities in the Republic of Ireland’s life sciences sector, making it an attractive market for foreign medicinal and medical device manufacturers. Market entry requires obtaining approvals from the Health Products Regulatory Authority (HPRA), which oversees registrations, licensing, and compliance.

Navigating Ireland’s complex regulatory landscape can be challenging, but it’s essential for successful market access. MedWisdom LifeScience offers comprehensive end-to-end Regulatory Affairs services to streamline the process and ensure compliance.

Medwisdom Lifescience offerings

• Strategic Regulatory Consulting
• Regulatory Affairs & Intelligence
• Registration Pathways and License Management
• End-to-End Operational Support
• Regulatory Submissions
• Dossier Preparation, Review, and Management
• Market Authorization and Licensing Services
• Post-Market Surveillance
• Labeling and Packaging Compliance