RegulatorIA — AI-Native Platform for Agrochemical Registration

The Platform

Your entire regulatory process,
in a single dashboard.

Manage dossiers, track statuses and get expiry alerts — all from an interface built for regulatory teams.

Interactive demo · click an agent in the menu

🔒 app.regulatoria.cl/dashboard

Ana Araya — Regulatory Affairs ▾

Active Dossiers

↑ +6 vs. last month

Overall Progress

68%

21/31 registrations in progress

Time Saved

1,248

hours this month

Estimated ROI

3.2x

Return on investment

Regulatory Registrations

Product	Country / Authority	Status	Progress	Expiry
Herbex 480 SC REG-CHL-2024-1021	🇨🇱 Chile · SAG	In progress	75%	15/08/2024
InsectoMax 20 EC REG-ARG-2024-0877	🇦🇷 Argentina · SENASA	In progress	60%	22/07/2024
FungiPro 250 EW REG-BRA-2024-0733	🇧🇷 Brazil · ANVISA	In progress	40%	10/09/2024
FoliarZn 700 SC REG-BRA-2024-0419	🇧🇷 Brazil · ANVISA	Approved ✓	100%	12/06/2024

Countries analysed

LATAM markets

Requirements detected

184

per jurisdiction

Optimal route

Equivalence

−40% time

Estimated time

8 months

shortest route

COMPASS · Regulatory strategy by countryUpdated 3 min ago

Country / Authority	Regulatory route	Key requirements	Est. time
🇨🇱 Chile · SAG	Full registration	Tox + eco-tox + residues	8 months
🇧🇷 Brazil · MAPA/IBAMA	Technical equivalence	Identity + 5 batches	10 months
🇦🇷 Argentina · SENASA	Registration by similarity	Local efficacy	6 months
🇨🇴 Colombia · ICA	Full registration	GLP studies	9 months
🇵🇪 Peru · SENASA	Equivalence	MRL + label	5 months

QSAR models

endpoints run

Endpoints predicted

tox + eco-tox

Read-across analogues

similar structures

Avg. confidence

91%

cross-validation

PREDICT · QSAR / read-across predictionsActive ingredient · Herbex

Endpoint	Method	Prediction	Confidence
Mutagenicity (Ames)	QSAR	Negative	94%
Acute oral tox. (rat)	Read-across	Category 4	88%
Carcinogenicity	QSAR	Not classified	90%
Daphnia magna (EC50)	QSAR	11.4 mg/L	92%
Biodegradability	Read-across	Rapid	89%

Variants generated

chemical space

Max tox. reduction

54%

vs. base molecule

Efficacy retained

≥90%

predicted

Viable candidates

for synthesis

GENESIS · Less toxic molecular variantsMulti-objective optimisation

Variant	Structural change	Toxicity	Efficacy	Viability
Analogue G-02	Cl→F substitution	↓ 38%	95%	Viable
Analogue G-05	Amide bioisostere	↓ 52%	88%	Evaluate
Analogue G-07	Methoxy group	↓ 31%	97%	Viable
Analogue G-11	Saturated ring	↓ 54%	84%	Evaluate
Analogue G-14	Branched chain	↓ 22%	99%	Viable

Regulations monitored

312

7 jurisdictions

Changes detected

this month

MRLs updated

last 30 days

Impact alerts

require action

SCOUT · Regulatory changes and MRLs detectedLive monitoring

Change detected	Country / Source	Type	Impact
New chlorpyrifos MRL 0.01 mg/kg	🇪🇺 UE · EFSA	LMR	High
Glyphosate restriction, urban use	🇨🇱 Chile · SAG	Regulation	Medium
Copper MRL update	🌐 Codex Alimentarius	LMR	Low
GHS reclassification, deltamethrin	🇧🇷 Brazil · IBAMA	Regulation	High
New eco-tox requirement for bees	🇦🇷 Argentina · SENASA	Regulation	Medium

Modules

8/10

of the dossier

Documents

142

indexed

Completeness

86%

ready for QC

Ready to file

dossiers

BINDER · Herbex 480 SC dossier — Chile / SAGCADRI format

Module	Docs	Status	Completeness
Identity and composition	12	Complete ✓	100%
Physicochemical properties	9	Complete ✓	100%
Toxicology	24	In process	70%
Eco-toxicology	18	Complete ✓	100%
Residues and MRLs	11	In process	55%
Label and SDS	6	Complete ✓	100%

Validations

1,204

rules applied

Critical findings

block filing

Warnings

to review

Compliance

94%

vs. SAG guidance

AUDITOR · Validation findingsHerbex 480 SC

Section	Severity	Finding
Subchronic toxicity study	Critical	Missing GLP statement (p.12)
Label — GHS pictograms	Warning	GHS07 pictogram missing
Residues — analytical method	Critical	LOQ does not meet target MRL
Chemical identity	OK	Compliant
Eco-tox — Daphnia	Warning	Missing statistical validation

Objections

received

Answered

filed on time

In preparation

AI draft

Success rate

91%

accepted

DEFENDER · Authority objectionsOpen notices

Notice	Authority	Status	Deadline
OF-2024-1182 Eco-tox data	🇨🇱 SAG	Answered	12/06
OF-2024-0934 Crop MRL	🇦🇷 SENASA	In preparation	28/06
OF-2024-0771 Label	🇧🇷 IBAMA	Answered	03/06
OF-2024-1205 Analytical method	🇨🇱 SAG	In preparation	05/07
OF-2024-0810 Chemical identity	🇨🇴 ICA	Answered	30/05

Documents generated

386

this year

GHS labels

compliant

Technical data sheets

FDS / SDS

Languages

ES · PT · EN · FR

SCRIBE · Generated documentsRegulatory templates

Document	Type	Language	Status
Herbex 480 SC label	GHS label	ES	Generated
Safety Data Sheet	FDS / SDS	ES · PT	Generated
InsectoMax 20 technical data sheet	Technical data sheet	ES	Under review
Toxicology summary	Regulatory doc.	EN	Generated
FungiPro 250 EW label	GHS label	PT	Under review

Active countries

expansion

Translations

documents

Equivalences

regulatory

Dossier reuse

73%

less work

BRIDGE · Multi-country expansionBase: Chile dossier

Country / Authority	Adaptation	Reuse	Status
🇧🇷 Brazil · MAPA	Translation + local MRL	78%	In progress
🇲🇽 Mexico · COFEPRIS	Equivalence	81%	In progress
🇨🇴 Colombia · ICA	Local efficacy	65%	Approved
🇵🇪 Peru · SENASA	Label adaptation	88%	Approved
🇺🇾 Uruguay · MGAP	Equivalence	72%	In progress

Active registrations

128

in portfolio

Upcoming expiries

< 90 days

Active alerts

require action

Renewals

in progress

GUARD · Portfolio alertsPost-registration monitoring

Product / Registration	Type	Severity	Date
Herbex 480 SC REG-CHL-2024-1021	Expiry	High	15/08/2024
InsectoMax 20 EC REG-ARG-2024-0877	Renewal	Medium	22/09/2024
FungiPro 250 EW REG-BRA-2024-0733	Post-registration	Low	—
Herbex 480 SC Applicable MRL change	Regulatory change	High	30/07/2024
BioControl WP REG-COL-2023-0512	Expiry	Medium	11/2024

Real-time dashboardEvery registration status updated instantly

Agents available 24/7They work in parallel while you rest

Expiry alertsNever miss a critical regulatory deadline

SharePoint / Drive integrationUpload documents from where you already work

Comparison by Agent

What each agent does vs. a traditional consultancy

Each agent covers one service in the regulatory process: same quality, a fraction of the time and cost.

Service (Agent)	Traditional Consultancy	RegulatorIA
Phase I · Pre-Registration
COMPASS — Regulatory Requirements	Manual lookup per jurisdiction	Dynamic regulatory GPS
PREDICT — In silico toxicology	External studies (€50k-200k)	Automatic QSAR predictions-80% cost
GENESIS — Molecule Design	No equivalent exists	Generative Safe-by-Design
SCOUT — Regulatory Intelligence	Periodic manual review	Automated 24/7 monitoring
Phase II · Registration
BINDER — Document Management	4-8 weeks manual compilation	Completeness dashboard + Document AI4x faster
AUDITOR — GLP/OECD Review	Manual review (2-4 weeks)	3 niveles automáticos, >90% approval5x faster
DEFENDER — Technical Defences	External lawyers ($$$)	AI defences against objections
SCRIBE — SDS and Labels	2-3 weeks per product	16-section SDS + CLP/GHS, 30+ languages
Phase III · Post-Registration
BRIDGE — Global Harmonisation	Country-by-country registration (linear)	Adapts dossier for ANVISA/EPA/ECHA
GUARD — Licence Monitoring	Periodic audit (quarterly)	Email→SMS→ERP block alerts
Global Summary
Total time per registration	12-24 months	3-6 months4x faster
Documentation error rate	15-25%	<2%-90% errors
Scalability (multi-country)	Linear: more staff per country	Parallel: same agents∞ scalable

COMPASS — Regulatory Requirements

TraditionalManual lookup

RegulatorIARegulatory GPS

PREDICT — In silico toxicology

Traditional€50k-200k in studies

RegulatorIAAutomatic QSAR -80%

GENESIS — Molecule Design

TraditionalDoes not exist

RegulatorIASafe-by-Design

SCOUT — Regulatory Intelligence

TraditionalManual, periodic

RegulatorIA24/7 automated

BINDER — Document Management

Traditional4-8 weeks

RegulatorIADocument AI 4x

AUDITOR — GLP/OECD Review

Traditional2-4 weeks

RegulatorIA3 niveles, >90% 5x

DEFENDER — Technical Defences

TraditionalLawyers ($$$)

RegulatorIAAI defences

SCRIBE — SDS and Labels

Traditional2-3 weeks

RegulatorIACLP/GHS 30+ languages

BRIDGE — Global Harmonisation

TraditionalCountry by country

RegulatorIAANVISA/EPA/ECHA

GUARD — Licence Monitoring

TraditionalQuarterly

RegulatorIAEmail→SMS→ERP

Global Summary

Total time3-6 months 4x

Errors<2% -90%

ScalabilityParallel ∞

Human-in-the-Loop · HITL

AI supervised by regulatory experts.

We don't replace specialists: we empower them. Every critical AI decision is reviewed and validated by a certified regulatory expert before it reaches you.

🤖

Step 1 · AI

The AI generates

The 10 agents process your product: they analyse the formulation, predict toxicity, check regulatory requirements and compile the technical dossier automatically.

QSAR analysis Automatic dossier Regulatory check

👩‍🔬

Step 2 · Expert

The expert validates

A certified regulatory specialist reviews the critical points: toxicology studies, residue data, GLP/OECD compliance and overall consistency of the file.

GLP/OECD review Certified signature Technical audit

✅

Step 3 · You

You decide

You receive the validated file in your dashboard, ready to file with SAG or the relevant authority. You approve with one click and the platform handles the follow-up.

Interactive dashboard One-click approval Full traceability

🛡️

HITL quality guarantee

No dossier leaves the platform without expert review. This human-supervision model not only raises the regulatory approval rate, it guarantees there is always a professional accountable for every file.

>90%

Approval rate

<2%

Documentation errors

24h

Expert review time

Enterprise Security

Your regulatory data, protected at the highest level.

Registration files contain sensitive technical and commercial information. The platform was designed with enterprise-grade security from day one.

🔐

AES-256 + TLS 1.3 encryption

All your documents are stored encrypted at rest with AES-256. Client-server communications use TLS 1.3 with Perfect Forward Secrecy.

Data at rest and in transit

👥

Role-based access control (RBAC)

Define granular permissions per team: the regulatory team sees dossiers, the commercial team only registration statuses. Nobody accesses what isn't theirs.

Least privilege

📋

Immutable audit trail

Every action is logged: who accessed it, what they changed and when. The log is immutable and can be exported for regulatory audits or authority inspections.

Full traceability

🇨🇱

Data residency in Chile

Chilean clients' data is hosted on infrastructure within the country, in compliance with Law 21.719 on Personal Data Protection.

Ley 21.719

🔑

Multi-factor authentication (MFA)

Secure access with mandatory two-step authentication for all users. Compatible with TOTP (Google Authenticator, Authy) and FIDO2 security keys.

2FA / FIDO2

🌐

Per-client data isolation

Multi-tenant architecture with strict isolation: your company's data is never accessible to other clients. Production environment kept separate from testing.

Secure multi-tenant

🔒

ISO 27001

On 2026 roadmap

🛡️

GDPR Ready

DPA available

🇨🇱

Ley 21.719

Data in Chile

📝

GLP / OECD

GxP traceability

🔐

AES-256 / TLS 1.3

End-to-end encryption

☁️

99.9% uptime

Guaranteed SLA

Frequently asked questions

What people ask us before getting started

Common questions about timelines, countries, regulations and the human expert's role in the process.

What is RegulatorIA and what is it for?

RegulatorIA is an AI-native platform that automates the registration of agrochemicals and pesticides with LATAM regulatory authorities. It combines 10 specialised artificial intelligence agents —covering everything from regulatory strategy and in silico toxicology to dossier assembly and post-registration monitoring— with mandatory validation by human regulatory experts before every delivery.

How long does it take to register an agrochemical with RegulatorIA?

A significant part of a registration timeline goes into preparing, reviewing and correcting the file. RegulatorIA cuts up to 80% of the time spent on that documentation and analysis stage: dossier assembly, GLP/OECD review and responses to objections go from weeks to days. Each authority's own evaluation timelines do not change, since they depend on the agency.

In which countries can I register products with RegulatorIA?

The platform operates in Chile (SAG), Argentina (SENASA), Brazil (IBAMA/ANVISA/MAPA), Colombia (ICA), Peru (SENASA) and Mexico (COFEPRIS/SENASICA). In addition, the BRIDGE agent adapts dossiers to international formats such as EPA (United States), ECHA (European Union) and ANVISA.

Does artificial intelligence replace the regulatory expert?

No. RegulatorIA runs on a HITL (Human-in-the-Loop) model: the AI does the heavy lifting of research, analysis, drafting and quality control, but no document is filed with an authority without the review and signature of a senior regulatory expert. 100% of deliverables go through human validation.

Which regulations, formats and agencies does the platform support?

RegulatorIA works with the formats and standards required in the region and beyond: CADRI, GLP and OECD guidelines, GHS and CLP classification (EC Regulation 1272/2008), 16-section safety data sheets (SDS), labelling in over 30 languages, and the filing formats of SAG, SENASA, ICA, COFEPRIS, ANVISA, EPA and ECHA.

How is the confidentiality of my dossiers and data protected?

Data is handled with enterprise-grade security: encryption in transit and at rest, per-client isolation, role-based access control and full traceability of every action on the file. The technical information on your molecules and studies is never used to train models nor shared with third parties.

Can I reuse a dossier approved in Chile to register in other countries?

Yes. That is exactly what the BRIDGE agent does: it takes an already-approved dossier and adapts it to the destination country, identifying which studies can be reused, which need supplementing and which equivalences apply between regulations. This avoids repeating expensive studies and significantly shortens the second and third registrations.

What if my company has no regulatory department?

There is a managed-service option designed for agrotech and biotech startups without their own regulatory team. A team of senior experts, supported by the platform, takes charge of the entire registration: strategy, dossier assembly, filing with the authority, responses to objections and ongoing follow-up.

How do I get started with RegulatorIA?

You can request a personalised demo from the form on this page. We arrange a live session with a regulatory expert within 48 hours, where we review your specific product and show you how the platform would handle its registration end to end.

The software that automates your registration of agrochemicals.

Your entire regulatory process,
in a single dashboard.

One orchestrator. 10 agents. 3 phases.

Three phases. Zero friction.

What each agent does vs. a traditional consultancy

No regulatory team? We register it for you.

Strategy

Complete dossier

Filing and management

Follow-up

You focus on your product. We focus on getting it to market.