GxP Signal is the pharma intelligence layer that makes any AI gateway inspection-ready, quality-validated, and regulatory-compliant. It plugs into your existing stack — no rip-and-replace.
Generic gateways treat a regulatory submission draft the same as an internal meeting summary. The FDA, EMA, and EU AI Act don't. Neither should your infrastructure.
Every task routes through premium models as a safety default. Literature screening gets the same model as an NDA submission — 55% overspend on tasks that don't require it.
Generic audit logs don't capture task classification, risk tier, or quality validation. When the inspector asks which model generated an output, the answer is silence.
Does the output reference the correct ICH guideline? Is the MedDRA terminology valid? Are there unsupported efficacy claims? Generic tools can't check what they don't understand.
GxP Signal sits alongside your AI gateway. It adds the pharma intelligence layer. Your gateway handles routing. We handle compliance.
Each built from pharma domain expertise that horizontal tools cannot replicate.
Categorizes every AI request by pharma task type — regulatory writing, clinical summarization, pharmacovigilance, literature review, medical information — and assigns a regulatory risk tier. GxP-Critical tasks never get downgraded.
Generates 21 CFR Part 11 and EU Annex 11 compatible audit records. Model ID, version, prompt hash, response hash, quality score, routing rationale — the format your QA team needs for inspections.
ICH guideline compliance, MedDRA terminology accuracy, CTD structural consistency, clinical claims screening, and citation verification. Quality gates generic tools will never build.
Recommends the optimal model tier based on regulatory risk. Enforces hard floors for GxP-critical tasks. Triggers fallback to premium when quality checks fail. Your gateway routes — we advise which route is safe.
Prompt injection detection, PII/PHI scanning on both input and output. GxP-Critical requests are blocked on injection detect. Protects regulated workflows from data leakage and prompt manipulation.
Simulated across 7 task categories using realistic pharmaceutical AI workloads. Full audit trail, quality validation, and cost analysis on every request.
| Risk Tier | % of Requests | Before (all premium) | After (GxP Signal) | Savings |
|---|---|---|---|---|
| GxP-Critical | 35% | $2.79 | $2.79 | 0% — quality floor |
| GxP-Adjacent | 42% | $3.38 | $0.68 | 80% |
| Non-GxP | 23% | $1.77 | $0.09 | 95% |
GxP Signal processes content in-memory for classification and validation, then discards it. Only metadata and SHA-256 hashes are stored. The platform improves from aggregate patterns without ever seeing regulated content.
When the inspector asks how your AI made a decision, GxP Signal provides the complete record — model version, prompt hash, quality validation, and routing rationale.
Designed for 21 CFR Part 11 and EU AI Act Article 12 traceability. Compatible with existing QMS workflows. Exports to CSV, PDF, and standard audit formats.
GxP Signal is in early access. If you're deploying AI in pharmaceutical development and need compliance you can defend, we should talk.