What industries do you serve?
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We primarily serve pharmaceutical, biotech, biologics, and health sciences organisations — any environment regulated under FDA, EMA, ICH, PIC/S, or MHRA frameworks. We also support CDMOs, CMOs, cell and gene therapy manufacturers, and medical device companies where GxP compliance overlaps with ISO 13485.
How is eCQV·GxP different from a traditional consulting firm?
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Three things. First, we are practitioners — every team member has worked inside regulated facilities, not just advised them. Second, we are the only practice that combines CQV validation and GxP compliance with purpose-built agentic AI — so we don't just advise on the strategy, we deploy the technology that executes it. Third, every engagement begins with deep discovery, not a scope of work — we earn your trust before we scope your project.
Can you deploy AI in our GMP environment safely?
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Yes — and this is what makes us unique. Our agentic AI platform is designed from the ground up for regulated environments. Every agent deployment comes with a complete governance package: intended use documentation, risk assessment, training data controls, human-in-the-loop gating at critical decision points, and a full validation record. We've had zero FDA 483 observations related to AI across all our engagements.
What does your engagement model look like?
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We start with a structured discovery conversation — typically 60–90 minutes — to understand where your real compliance pain is concentrated. We don't pitch before we listen. From there, we identify the highest-impact opportunity, design a focused engagement scope, and deliver against it. Engagements range from targeted advisory projects to full AI platform deployment and ongoing governance support.
Do you work with sites facing active FDA scrutiny?
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Yes. Our team has supported sites through Warning Letter response, consent decree remediation, and pre-inspection readiness — across FDA, EMA, and MHRA. If you have an upcoming inspection, an outstanding 483, or a Warning Letter to respond to, these are exactly the situations where our speed and regulatory depth are most valuable. Please indicate urgency in your message and we will prioritize the response.
What is your typical project timeline?
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Timelines vary by scope. A targeted AI-backed deviation management assessment can be delivered in 4–6 weeks. A full CPV program with AI monitoring deployment typically runs 3–6 months. Process automation and validation projects scale with system complexity. We are honest about timelines — and our AI platform consistently compresses documentation cycles by 50–70%, which accelerates delivery across all engagement types.