Secure · reviewable · auditable regulatory automation

From study report to IUCLID-ready endpoint record — with expert control.

Frogmative AI helps regulatory teams turn toxicology study reports into structured, reviewable IUCLID-ready endpoint records. AI drafts the fields, experts approve the evidence, and every decision is audit-logged.

Working vertical slice: repeated-dose oral toxicity → reviewed fields → validated .i6z → ECHA IUCLID Cloud import.

The problem

Where dossier work gets stuck

Extraction alone is not enough. Regulatory teams need traceability, review, controlled export, and confidence that the expert remains responsible for every value.

Manual extraction

Pulling structured fields out of long, inconsistent study reports is slow and error-prone.

Untraceable decisions

Which value was used, why, and from which page — hard to evidence and defend later.

IUCLID preparation

Producing consistent, import-valid IUCLID content adds another manual, fragile step.

The Frogmative workflow

From PDF to IUCLID — with expert control

Step 1
Study report (PDF)
Step 2
Secure upload
Step 3
Structured AI extraction
Step 4
Expert review & approval
Step 5
Validated .i6z export
Step 6
IUCLID import + audit

Inside Frogmative Workbench

The expert stays in control

A case holds the source document, the AI extraction, the reviewed fields, exports, and a full audit history. The AI value is never the final value — the reviewed value is.

Case: Lambda-cyhalothrin — 12-month oral dog study
Under review
FieldAI valueReviewed valueConf.SourceStatus
GuidelineOECD 408OECD 409highp.1Approved
Speciesdogdoghighp.2Approved
NOAEL0.1 mg/kg bw/day0.1 mg/kg bw/dayhighp.9Approved
LOAEL0.5 mg/kg bw/day0.5 mg/kg bw/dayhighp.9Approved
Target systemnervous systemnervous systemmediump.9Approved

Illustrative panel. The Guideline row shows an expert correction (AI draft → reviewed value).

Audit trail
  1. Document uploaded
    study report (PDF) → encrypted storage
  2. Extraction completed
    Claude Sonnet · 35-field schema · source-cited
  3. Field updated
    Guideline: OECD 408 → OECD 409
  4. Fields approved
    40 fields approved by reviewer
  5. Export generated
    IUCLID .i6z (validated)

The approach

Not a chatbot. Not blind automation.

AI drafts into a fixed schema

Extraction targets a defined toxicology endpoint schema — not free-form chat output.

Expert reviews field-by-field

Every field shows the AI draft, confidence and source page. The expert edits and approves.

Export uses reviewed values

Only approved values are exported, and every action is recorded in an audit trail.

Security & data handling

Built for regulatory trust

Authenticated, organization-scoped access (AWS Cognito)
Private, encrypted document storage (S3 + KMS)
AI runs server-side through a gateway
Amazon Bedrock (Claude) production path, EU region
The browser never holds a model key
Customer data is not used to train foundation models
Full audit trail of every action
Retention configurable

Pilot-grade secure architecture designed for enterprise hardening. We do not claim production certification, blanket zero-retention, or 100% compliance.

What works today

Proven into the official ECHA IUCLID Cloud

A repeated-dose oral toxicity study (12-month dog study) was processed end-to-end and the generated package imported into the official ECHA IUCLID Cloud as a real endpoint record.

Study report uploaded
Step 1
Structured fields extracted
Step 2
Fields reviewed & approved
Step 3
IUCLID .i6z generated
Step 4
Imported into ECHA IUCLID Cloud
Step 5

Working vertical slice for one study type — not a full dossier generator yet.

What we need next

A validation case turns this into a pilot

One representative source PDF we can validate against
The corresponding human-prepared output, to compare field-for-field
Agreement on the first study type to support deeply
One named pilot user
The IT / security questions a customer would ask before uploading documents

Open Frogmative Workbench

See the working vertical slice — secure upload, AI extraction, expert review, validated IUCLID export, and a full audit trail.