Driftpin Consulting helps life sciences organizations implement, validate, and scale compliant technology systems with practical, risk-based strategies.
About Driftpin
Welcome to Driftpin Consulting—your trusted partner in navigating the complexities of life sciences technology and compliance. We empower pharmaceutical companies, biotechnology firms, Clinical Research Organizations (CROs), and GxP software developers to achieve regulatory excellence through innovative, risk-based, and pragmatic solutions.
With expertise in AI integration, system validation, regulatory compliance, and change management, Driftpin ensures your organization is equipped for today’s challenges and positioned for tomorrow’s opportunities in digital healthcare.
Why Clients Choose Driftpin
Do you have a problem that needs solving?
You can set us loose and forget about it—we’ll take it off your plate and get it done. One less thing to worry about.
Whether it’s a system that isn’t working, validation slowing your project down, or compliance keeping your team stuck, we’re here to fix it. Quickly, quietly, and with the right amount of process—not more than you need.
We’ve seen the patterns before and know how to cut through the noise. Our approach is grounded in:
- Risk-based execution: We focus where the real risk is—not just where the templates say to.
- Technology fluency: Deep experience with implementation, validation, integration, and AI across regulated platforms.
- Operational alignment: We make sure systems actually support how work gets done—usable, auditable, and sustainable.
- Collaborative scale: We’re a lean consultancy backed by a trusted network of professionals with 20+ years in clinical operations, software development, data management, and quality systems.
Clients don’t need lectures—they need clarity, ownership, and a solution that sticks. That’s what we do.
Leadership in Life Sciences
Driftpin Consulting is led by Kevin Shea, a seasoned professional with over two decades of experience in the life sciences industry. Kevin combines deep technical knowledge with a hands-on approach to help organizations excel in regulatory environments and drive operational success.
Key Achievements
- ISO Certification Leadership: Successfully directed ISO 9001 and ISO 27001 certification initiatives, strengthening quality and security systems.
- AI-Driven Compliance: Guided organizations in leveraging AI for Computer System Validation (CSV), risk management, and operational efficiency.
- Regulatory Expertise: Developed and implemented Quality Management Systems (QMS) tailored to industry best practices.
- Collaborative Transformation: Empowered teams to align with compliance goals while fostering innovation.
Kevin’s innovative mindset and dedication to excellence position Driftpin as a trusted partner for life sciences organizations.
How We Help
We partner with clients to deliver tailored solutions that solve complex challenges and ensure compliance.
Industries We Serve
- Pharmaceutical Companies: Optimizing compliance and operational performance.
- Biotechnology Firms: Supporting innovation with validated systems and processes.
- CROs: Streamlining technology adoption and maintaining audit readiness.
- GxP Software Developers: Facilitating ISO certifications, software validation, and risk management.
Our Expertise
AI in Life Sciences
Harnessing AI to improve CSV, predictive analytics, and process automation while adhering to GxP standards.
System Validation & Implementation
Ensuring seamless integration and compliance for critical software systems to enhance operational efficiency.
Regulatory Compliance
Simplifying FDA, EMA, ISO 9001/27001, and GAMP 5 requirements to ensure audit readiness.
Change Management
Guiding strategic transformations to adapt to evolving regulatory and market demands.
AI Strategies for GxP Operations
Driftpin is at the forefront of integrating AI into GxP-regulated environments, blending innovation with compliance.
What We Offer
- AI models for predictive maintenance, process optimization, and risk management.
- Compliance-focused AI strategies aligned with CSA and GAMP 5.
- Training programs to empower teams to adopt AI responsibly.
Our Network of Partners
Our collaborations with leading industry experts enhance our ability to deliver innovative solutions.
- Valkit.ai: Advanced analytics and AI-driven insights.
- CellPort Software: Secure, compliant clinical software solutions.
- StrikeGraph: Simplifying ISO certification with powerful tools.
Learn more on our Partners page.
Meet Kevin Shea
Before entering the life sciences industry, Kevin Shea honed skills in precision, safety, and adaptability as a commercial diver and welder in the Gulf of Mexico. Transitioning to life sciences in 2001, Kevin has become a recognized leader, helping organizations transform challenges into opportunities through operational excellence and strategic innovation.
Let’s Collaborate
Ready to overcome challenges and drive success? Contact Driftpin Consulting today to learn how we can support your goals.
- Phone: 610-772-5726
- Email: info@driftpin.com
Driftpin Consulting—navigating complexities, delivering solutions, and driving success.