Accelerating innovation through intelligent compliance
We are a pioneering partner in life sciences, dedicated to reducing regulatory complexity so you can deliver therapies faster. Our expertise transforms compliance from a traditional constraint into a strategic advantage, enabling organizations to embrace digital transformation with confidence and precision.
Our Story
Velocity Through Integrity
Traditional compliance often feels like a brake on innovation, creating friction between regulatory requirements and the pace of technological advancement. We fundamentally challenge this paradigm by transforming governance, risk and compliance into an engine for digital velocity. Our approach recognizes that safety and speed are not opposing forces but they are complementary objectives that, when properly aligned, accelerate the delivery of life-saving therapies to patients worldwide.
We specialize in helping life sciences organizations harness the transformative power of artificial intelligence and digital transformation whilst maintaining an unwavering commitment to patient safety and data integrity. Our methodology doesn't compromise on regulatory rigor. Instead, it streamlines processes through intelligent risk assessment and strategic automation.
Our Expertise
By seamlessly blending cutting-edge technologies with established frameworks such as GAMP5 and Quality Risk Management, we ensure your systems are audit-ready at the speed of innovation. We don't just help you meet regulatory requirements, we build compliant digital ecosystems that become competitive advantages, enabling you to move faster than your competitors whilst maintaining the highest standards of quality and safety.
Regulatory Intelligence
Deep understanding of FDA, EMA, and MHRA expectations for digital systems and data integrity. We translate regulatory guidance into practical implementation strategies that inspectors understand and approve.
Technical Proficiency
Comprehensive knowledge of CSV, CSA, data integrity, and GxP-AI validation methodologies. Our technical frameworks are battle-tested across hundreds of successful implementations and regulatory inspections.
Industry Recognition
Published authors, conference speakers, and thought leaders who actively shape industry standards and best practices. Their insights influence how regulators think about digital transformation.
Leadership
Guided by Industry Authorities
Our leadership team brings decades of combined expertise in governance, risk and compliance in the life sciences, digital transformation, and regulatory strategy. Their deep knowledge and forward-thinking approach ensure that every client engagement is informed by both regulatory excellence and technological innovation.
Dr. Eva Kelly
Expertise: PhD in Chemistry, Data Integrity, GMP, 21 CFR Part 11
Dr. Kelly is a recognized authority in remediation and governance strategies for complex regulatory environments. Her extensive background ensures that both on-premise and cloud-based systems meet the highest global standards of ALCOA++ compliance. She has successfully guided numerous organizations through complex data integrity challenges, transforming potential compliance risks into opportunities for operational excellence.
Andy O'Connor
Expertise: GxP-AI Strategy, Probabilistic Risk, CSV/CSA, Application Lifecycle Management
Andy leads the development of Phanero, an innovative platform specifically designed for AI and machine learning validation in regulated environments. He bridges the gap between operational velocity and GxP discipline, helping organizations adopt emerging technologies without compromising compliance. His focus on probabilistic risk management is helps to create a new GxP-AI framework for intelligent automation in life sciences.
Our North Star
Mission & Vision
Vision
Pioneering the future of compliant digital ecosystems, where artificial intelligence and automated assurance accelerate the delivery of life-saving therapies. We envision a world where regulatory excellence and technological innovation are inextricably linked, creating sustainable competitive advantages for forward-thinking organisations.
Mission
To eliminate the complexity of regulatory compliance through intelligent risk-based approaches and AI assurance, enabling confident adoption of transformative technology. We empower life sciences organisations to embrace digital transformation without hesitation, knowing that every innovation is built on a foundation of robust compliance and unwavering quality.
These guiding principles inform every strategic decision we make, ensuring that our clients can navigate the evolving regulatory landscape with confidence and clarity. We don't just help you comply, we help you lead.
Core Values
Our Operating Principles
These fundamental principles ensure that speed and safety coexist harmoniously in every engagement. They represent our commitment to excellence and our belief that compliance, when approached intelligently, becomes a catalyst for innovation rather than an obstacle to progress.
Bold Innovation
We challenge the status quo by implementing the cutting edge of GxP-AI methodologies. Our team actively explores emerging technologies and pioneering approaches, ensuring our clients benefit from the latest advances whilst maintaining full regulatory compliance. Innovation isn't just encouraged, it's embedded in our DNA.
Patient-Centric Risk Management
We prioritize patient safety in every decision, ensuring that compliance serves a higher purpose beyond mere regulatory adherence. Our risk assessment frameworks are designed with the patient at the centre, guaranteeing that every system, process, and decision ultimately contributes to better patient outcomes and enhanced public health.
Human-Centric Intelligence
We champion critical thinking and human expertise to mitigate algorithmic bias and align cross-functional teams. Whilst we embrace automation and AI, we recognize that human judgement remains irreplaceable in complex regulatory environments. Our approach harmonizes technological capability with human wisdom and ethical consideration.
Uncompromising Data Integrity
We uphold ALCOA++ principles as the foundation for evidence-based decision-making and regulatory confidence. Data integrity isn't negotiable, it's the bedrock upon which all compliant systems are built. Our rigorous approach ensures that every data point is attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available.
Agile Lifecycle Excellence
We drive continuous compliance from concept through retirement, recognizing that regulatory assurance is not a one-time event but an ongoing commitment. Our agile methodologies ensure that systems remain compliant throughout their entire lifecycle, adapting to changing regulatory requirements and evolving business needs with speed and precision.
Lead the future of life sciences
Don't let regulatory complexity slow your innovation
The future of life sciences belongs to organizations that can move quickly without compromising on quality or safety. Our team of regulatory experts and digital transformation specialists is ready to help you navigate the complexities of GxP compliance whilst accelerating your journey towards intelligent automation and AI-driven innovation.
Whether you're implementing new AI systems, modernizing legacy applications, or seeking strategic guidance on data integrity and quality risk management, we provide the expertise and partnership you need to succeed. Let's build the compliant digital ecosystem that will power your next breakthrough.
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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