Don't let regulatory complexity slow your innovation
Master GxP-AI and digital systems to lead the future of life sciences and deliver life-saving therapies to patients, faster.
Innovation with Integrity
Eliminate complexity through intelligent risk-based approaches
We eliminate the complexity of regulatory compliance (such as 21 CFR Part 11, Annex 11, Annex 22) through intelligent risk-based approaches and AI assurance. Our methodology transforms governance, risk and compliance into strategic advantage, enabling life sciences organizations to innovate confidently whilst maintaining the highest standards of patient safety and data integrity.
GxP-AI & Digital Strategy
Pioneering the future of compliant digital ecosystems and AI assurance. We architect robust frameworks that enable artificial intelligence deployment whilst ensuring governance, regulatory compliance and audit readiness for you.
Risk Strategy
Moving beyond documentation to patient-centric risk management. By utilizing probabilistic risk management and real-world impact analysis we ensure safety drives decision-making at every level for you.
Stakeholder Engagement
Human-centric intelligence that aligns cross-functional teams. We champion critical thinking to bridge the gap between human intent and technical execution, ensuring seamless implementation.
Compliance & Validation
Agile lifecycle excellence with comprehensive CSV/CSA support driving continuous compliance from concept to retirement. Our approach ensures your systems remain validated throughout their entire lifecycle.
Data Integrity Governance
Uncompromising ALCOA++ principles for evidence-based decision-making. We implement robust data governance frameworks that ensure your critical data remains attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available and traceable.
Trusted by leaders in life sciences
Our clients consistently achieve accelerated timelines whilst maintaining the highest regulatory standards. We've helped organizations across the life sciences sector transform regulatory compliance from a bottleneck into a competitive advantage. Here is what some of our clients have to say:
Master GxP-AI Compliance
Access our knowledge hub featuring insights, regulatory guidance, and practical frameworks for implementing AI and digital systems in regulated environments.
Leadership & Expertise
Bridging human intent and technical execution
ERA Sciences is a pioneering partner dedicated to eliminating regulatory complexity for life sciences organizations. We combine deep regulatory expertise with cutting-edge technological understanding to deliver solutions that enable innovation whilst ensuring patient safety and data integrity.
Our team, led by experts like Dr. Eva Kelly and Andy O'Connor, offers extensive governance, risk and compliance experience in the areas of data integrity, GMP, and ALCOA Plus compliance. We blend innovative approaches with established frameworks like GAMP5 to ensure your digital ecosystem is audit-ready. Our methodology transforms regulatory compliance from a constraint into a strategic enabler of business objectives.
Ready to Transform Your Digital Compliance Strategy?
Partner with ERA Sciences to navigate the complexity of GxP-AI implementation, computer system assurance, and data integrity governance. Our expert-led governance, risk and compliance approaches ensures you can innovate confidently whilst maintaining the highest regulatory standards.
Strategic Consultation
Tailored roadmaps for GxP-AI and digital transformation aligned with your organizational objectives and regulatory requirements.
Implementation Support
Hands-on expertise to deploy AI systems, validation frameworks, and data governance programs.
Training & Enablement
Comprehensive programs to build internal capability and ensure sustainable compliance excellence.
Quick Links
Suite 913,
The Greenway,
112-114 St Stephen’s Green,
Dublin,
D02TD28,
Ireland
The Greenway,
112-114 St Stephen’s Green,
Dublin,
D02TD28,
Ireland
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