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Found 15 results for "CGMP" across articles, medicines, trials, companies and the glossary
Industry
US Pharmaceutical Tariffs Update: Policy Realities, The Stockpile 'Unwind', and Ireland’s Strategic Position
An in-depth analysis of where US pharmaceutical tariff policies stand in mid-2026 under the Trump administration, analyzing recent CSO export data, inventory stockpiling corrections, MFN agreements, and Ireland’s strategic biopharma position.
Industry
US Biopharma Group Pfanstiehl Acquires Nestlé’s Former Askeaton Infant Formula Site in Landmark Mid-West Industrial Transition
In a major boost for Ireland’s Mid-West life sciences hub, US biopharma specialist Pfanstiehl has acquired Nestlé’s former Wyeth Nutritionals plant in Askeaton, Co. Limerick, establishing its first international manufacturing facility.
Industry
UK Pharma CV Guide 2026: MHRA Standards, Golden Triangle Hubs & Free ATS CV Builder
Complete 2026 guide to writing an ATS-compliant pharmaceutical CV in the UK. Features MHRA & ABPI standards, UK 2-page CV conventions, Golden Triangle recruitment benchmarks, and free ATS CV Studio tools.
Industry
US Pharma Resume Guide 2026: FDA cGMP Standards, ATS Formats & Free Builder
Master the US pharmaceutical resume format in 2026. Covers FDA 21 CFR compliance terms, 1-2 page US resume rules, major US biopharma hubs (Boston, SF Bay, NJ, NC Triangle), and free ATS resume tools.
Industry
Global Pharma Talent Corridor: Writing a Cross-Border CV for India, Ireland, UK & US Roles
The ultimate 2026 guide for international life science professionals moving between India, Ireland, the UK, and the US. Learn how to format GxP experience, CDMO backgrounds, and visa-ready ATS CVs.
Industry
Master the Ireland & EU Pharma CV in 2026: HPRA Standards, ATS Templates & Industry Examples
The definitive 2026 guide to writing an ATS-compliant biopharmaceutical CV in Ireland and the EU. Features HPRA & EU Annex 1 standards, GxP bullet point formulas, Irish regional hub insights, and free ATS CV Studio tools.
Pharmaceutical
The Anatomy of a Biologics Warning Letter: Deconstructing Genzyme Waterford’s FDA Audit
The FDA CBER warning letter issued to Genzyme Ireland’s Waterford site in June 2026 is a watershed moment for Irish biopharma. From 11x repeated filter tests to discarded checklists and unexplained deviation cancellations, we analyze the specific CGMP violations and detail what this compliance failure means for quality management across the sector.
Regulatory Affairs
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 Affairs
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.
Pharmaceutical
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.
LinkedIn
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.
MedTech
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.
LinkedIn
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.
Pharmaceutical
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.