eCQV·GxP delivers AI-backed commissioning, qualification, validation, and GxP compliance governance — purpose-built for pharma, biotech, and health sciences organizations that cannot afford to choose between rigor and speed.
Most firms operate in one world. We are built at the intersection of eCQV and GxP — with AI as the connective tissue that makes the combination more powerful than either domain alone.
Each engagement is led by practitioners who have authored protocols, managed FDA inspections, and built CPV programs from inside regulated facilities — not consultants reading guidance from the outside.
End-to-end strategy, protocol authoring, execution oversight, and summary reporting aligned with ASTM E-2500 and ISPE GAMP 5 risk-based frameworks.
Build or remediate QMS infrastructure — deviation management, CAPA workflows, change control, training systems, and management review frameworks.
Purpose-built AI tools for protocol drafting, deviation triage, root cause analysis, and CPV anomaly detection — GxP-validated and audit-ready from day one.
Risk-based validation of GxP software — MES, LIMS, EBR, QMS, SCADA — with full data integrity controls and 21 CFR Part 11 compliance built in.
AI-enhanced CPV programs that replace periodic manual statistics with near-real-time multivariate monitoring connected directly to your deviation and CAPA systems.
Policy, SOPs, model lifecycle frameworks, and validation packages for organizations deploying AI/ML in regulated GMP environments — before the auditor asks.
Every engagement follows a phased approach that prioritizes learning before building — so we solve the real problem, not the assumed one.
Structured conversations with QA/CQV heads to map where time, money, and audit risk are actually concentrated — not assumed.
We identify the one high-impact problem — documentation-heavy, audit-painful, budget-justified — where AI delivers the fastest, most defensible return.
Before a single line of AI code is written, we lock intended use, risk assessment, data governance, and change management. Regulatory posture is built in, not bolted on.
Advisory support or AI tool deployment — with ongoing model monitoring, performance review, and governance documentation your auditors will respect.
AI vendors don't speak GMP. QA consultancies don't understand AI risk. We occupy exactly that gap — with the regulatory vocabulary to protect you and the technical depth to deliver.
Our AI tools are designed inside-out — intended use documentation, risk assessments, training data controls, and change management built in. No regulatory retrofit required after the fact.
Every engagement is led by people who have authored protocols, managed investigations, survived FDA inspections, and built CPV programs — not consultants who have only read the guidance.
We start with deep discovery, never a pitch deck. Where our AI tools fit, we deploy them. Where they don't, we deliver the strategy anyway. Your outcome is the only metric.
Every deliverable — protocol, AI governance framework, CAPA analysis, or validation package — is structured to hold up under FDA or EMA scrutiny. Defensibility is not optional here.
Whether you're a VP of Quality facing an inspection, a Head of CQV drowning in documentation, or a C-suite leader trying to understand how AI fits your GMP strategy — we have the conversation you need.