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Found 7 results for "CGMP"
Regulatory
Data Integrity and Quality Oversight: Analyzing the FDA Warning Letter for Sanofi's Waterford Site
Following a January 2026 inspection, the FDA has issued a formal warning letter to Genzyme Ireland Limited in Waterford, citing data integrity concerns, uncontrolled checklists, and quality unit oversight gaps in the manufacturing of Thymoglobulin and Altuviiio.
Regulatory
FDA Fires Warning Shot at Sanofi's Irish Plant Over Data Cover-Up and Altuviiio Quality Failings
The FDA has issued a formal warning letter to Sanofi's Waterford facility, Genzyme Ireland Limited, citing data integrity breaches, discarded quality records, and botched deviation investigations in the production of haemophilia drug Altuviiio and transplant therapy Thymoglobulin.
News
Leading CDMO Companies in Ireland: Your Complete Guide to Contract Manufacturing in 2026
A comprehensive guide to the top CDMO companies in Ireland - from Hovione and Thermo Fisher in Cork to EirGen Pharma in Waterford and HiTech Health in Galway. Full profiles, capabilities, certifications, and facilities of Ireland's leading contract development and manufacturing organizations.
News & Insights
Setting Up Your LinkedIn Profile for Pharma and Life Science in Ireland
A complete step-by-step guide to building a LinkedIn profile that gets noticed by recruiters in Ireland's pharma, biotech, and MedTech sectors. Learn how to optimize your headline, write a compelling About section, and highlight FDA/HPRA compliance experience.
Regulatory Affairs
The Digital-First Regulatory Landscape: How Ireland's Life Science Sector Is Adapting to the EU AI Act, EHDS, and Governance by Design
A comprehensive guide for Irish pharmaceutical, MedTech, and life science professionals on the EU AI Act implementation, the European Health Data Space, cGMP compliance in an AI-driven environment, ALCOA+ in digital systems, and the practical steps organisations must take to achieve governance by design in 2026.
News & Insights
10 LinkedIn Profile Fixes That Will Get You Noticed by Irish Pharma Recruiters in 2026
Irish pharma recruiters scan hundreds of profiles daily. These 10 targeted optimisations will push your profile to the top of their shortlist - and most take under 10 minutes to implement.
Pharma & MedTech
How the Iran Conflict Is Disrupting Ireland’s Pharmaceutical Industry and Why It Matters Globally.
Middle East air route disruptions are raising costs and delaying Ireland’s pharma exports, impacting global medicine supply chains.