GxP Signal classifies pharma AI tasks by regulatory risk, validates outputs against ICH and MedDRA standards, generates 21 CFR Part 11 audit trails, and traces every claim back to its source evidence. In front of any LLM API or gateway.
EU AI Act enforcement is live. FDA and EMA inspectors are asking about AI governance now. Every AI interaction your team runs today without an audit trail becomes a question you cannot answer tomorrow.
Audit history cannot be backfilled. Governance maturity is not retroactive. 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. And you can't build six months of audit history retroactively.
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 between your application and your LLM provider. No gateway required. Works directly with any LLM API — or with gateways like Portkey, Bifrost, and LiteLLM.
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. Every AI-assisted analysis and draft is timestamped and searchable, so when leadership asks "where did we explore this indication?", the answer is in the audit trail.
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. Also reduces gateway logging costs by enabling metrics-only mode for Non-GxP requests — saving on Portkey, Bifrost, and LiteLLM log volume fees.
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.
Every AI-assisted passage carries its complete evidence chain — source data tables, regulatory guidance citations, validation results, and the full reviewer chain. When an inspector asks "where did this sentence come from?", the answer is one click away. Pilot partners welcome.
Sourced from public pharmaceutical content — FDA guidance language, ICH guidelines, ClinicalTrials.gov patterns, EMA regulatory procedures, and PubMed abstracts. Every prompt is human-labeled across 7 task categories and 3 regulatory risk tiers.
| 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% |
Enter any pharma AI prompt and see how GxP Signal classifies it by task type, risk tier, and recommended model routing. Runs entirely in your browser.
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. Next on the roadmap: claim-level provenance — see below.
An audit trail tells the inspector that AI was used. Provenance tells them where the evidence came from — for every claim, every sentence, every citation.
Click any AI-assisted passage in your submission. See the source data tables, the ICH guidance referenced, the validation checks that ran, and the full reviewer chain. Hours of manual cross-referencing becomes seconds.
See an inspector's view →Building this as the next major capability. Pilot partners welcome — regulatory writers and CMC leads who want early access should reach out.
GxP Signal is this pharma intelligence layer that makes any AI workflow inspection-ready, quality-validated, and regulatory-compliant. Works directly with LLM APIs or any gateway — no rip-and-replace.