Managing pesticide registrations across US EPA, EU, and Brazil in one platform
A workflow-driven regulatory affairs management system that automates form generation (EPA 8570 series), tracks data requirements across jurisdictions, manages multi-stage review/approval workflows, and calculates PRIA fees — replacing months of manual document assembly.
The Challenge
When a company wants to sell a pesticide product in any market, they must first get approval from that country's regulatory agency. In the US, that's the EPA. In Europe, it's a complex zonal system spanning 27 countries. In Brazil, it requires parallel submissions to three separate agencies. This process is extraordinarily complex.
Each registration can take 1-3 years and cost between $50,000 and $500,000+. The data requirements span hundreds of individual data points covering chemistry, toxicology, environmental fate, efficacy, and more. A single missing study or incorrectly formatted form can result in rejection and months of delays.
Our client's regulatory affairs team was managing registrations across US EPA, European Union, and Brazil using a patchwork of spreadsheets, shared drives, and email chains. This led to missed deadlines, duplicated effort across markets, and submission rejections from incomplete data packages. They needed a unified system that understood the nuances of each regulatory framework.
Our Approach
We spent the first three weeks embedded in the regulatory affairs workflow — not writing code, but learning. We studied EPA 8570 form series and PRIA fee structures. We mapped EU zonal authorization requirements across North, Central, and South zones, understanding the role of Rapporteur Member States and how mutual recognition works. We dissected Brazil's unique 3-agency parallel submission process involving MAPA (agriculture), ANVISA (health), and IBAMA (environment).
This domain immersion revealed that while each market has different requirements, there's a common data core — the fundamental chemistry, toxicology, and efficacy data that every regulator needs, just formatted differently. We architected the system as a workflow engine with market-specific modules that share this common data foundation.
The key insight was treating regulatory submission as a state machine. Every project moves through defined stages (Draft → In Review → Approved → Ready to Submit → Submitted → Registered), with role-based permissions controlling who can advance the state. This gave us a framework that could handle any market's workflow while maintaining audit compliance.
What We Built
Project Dashboard
A completeness heatmap showing data readiness across all active projects, status pipeline visualization, and market summary cards. Regulatory affairs managers see at a glance which projects need attention and which are on track.
New Project Wizard
A 6-step guided flow for setting up new registration projects. Market-specific configuration includes EU zone and RMS/CMS selection, EPA PPLS lookup for reference products, and Brazil agency routing. The wizard ensures no critical setup step is missed.
Dynamic Data Matrix
A checklist that adapts based on the selected market, showing required studies, GLN requirements, available waivers, and completion status for each data point. As the team uploads documents and marks items complete, the matrix updates in real-time.
Auto-Generated EPA Forms
The system populates EPA 8570-series forms directly from entered data, eliminating manual document assembly. Form fields are pre-filled, calculations are automated, and the output is submission-ready PDF.
Label Builder
Regulatory label generation with automatic signal word determination, GHS/CLP classification, and H/P-statement selection. Ensures labels meet regulatory requirements for each market.
Fee Calculator
PRIA fee computation for EPA submissions, RMS/CMS fee breakdown for EU applications, and 3-agency fee calculation for Brazil (with company size tiers). Teams can budget accurately before starting submissions.
The Outcome
The regulatory affairs team transformed their workflow from scattered spreadsheets to a unified platform. What once took 45 days of document preparation now takes under 8 days. First-pass approval rates improved significantly by eliminating incomplete submissions.