About T12 Consult
Empowering GxP Compliance with Risk-Based Expertise
At T12 Consulting, we specialize in helping biopharmaceutical and medical device companies implement and validate GxP-regulated systems and processes with confidence. With a strong foundation in FDA and EMA expectations, we offer pragmatic, risk-based compliance strategies focused on Computer System Validation (CSV), data integrity, and regulatory readiness.
We bring deep experience in regulated environments, delivering tailored support that aligns with evolving guidance — including GAMP 5, ICH E6(R2), Annex 11, and the FDA's Computer Software Assurance (CSA) approach.
✅ Right-sized. Risk-based. Audit-ready.
About T12 Consulting
T12 Consulting was founded to bring practical, quality-driven support to life science companies managing complex GxP systems.
Our mission is to make compliance more effective, less burdensome, and fully aligned with global regulatory expectations — so that regulated teams can innovate without fear of audit findings or delays.
Our Promise
We don’t just check boxes. We help you build quality systems that support innovation, reduce risk, and stand up to regulatory scrutiny — without slowing you down.
Why T12?
- Practical strategies that avoid overvalidation
- Current with FDA, EMA, and global guidance
- Hands-on support from seasoned consultants — no handoffs, no fluff
- Clear documentation and risk-based frameworks that hold up under scrutiny
Whether you’re launching a new system, remediating data integrity gaps, or preparing for an inspection, we deliver targeted solutions that scale with your needs.