For 10 years we've been living inside a problem almost no one outside can see.
Experienced professionals carrying the company's reputation on their backs, operating with email, spreadsheets, Outlook and network folders. It happens in pharma, agribusiness, food, insurance, medical devices. In quality, compliance, regulatory, legal.
When audit asks "was this assessed?", the answer depends on the memory of whoever was there.
I lived this before founding Sigalei.
Product engineer in a regulated industry, dealing with certification, Anvisa and heavy documentation. Working hard and still being caught by a detail that slipped by, because the detail was in the paragraph of a technical note no one read in time.
It's a problem we're solving because it has already hurt me.
The cost of the status quo has become too high.
At one agribusiness client, 3,000 regulations became 8,000 in three years. The team didn't grow at the same pace. No team does.
Volume goes up. Complexity goes up. Risk goes up. "Alert plus spreadsheet plus email" stopped being enough.
documents monitored per month on the platform
agencies and official sources covered (DOU, state and municipal gazettes, ANVISA, CADE, CONEP, MAPA, SUSEP, among others)
active regulations tracked on the platform
segments served: pharma, agribusiness, food, insurance, medical devices, GRC
Every regulatory area operates on three layers at the same time.
Knows that it knows
Regulations mapped, processes under control.
Knows that it doesn't know
Relevant sources not being read for lack of capacity.
No one has mapped it yet
A new agency, a structurally different flow, a sentinel hospital complaint that becomes a notification tomorrow.
Sigalei clears the second, organizes the first and gives time back to the third.
Regulatory is text. It doesn't fit in a spreadsheet.
Regulatory is dense text, full of context. Most tools only work by breaking everything into tables, and lose what matters: meaning.
Sigalei works with text, semantic search and connected objects. It's the leap from spreadsheets to AI with governance.
Instead of you reading 200 documents to find the 3 that matter, specialized agents read for you, classify by risk and opportunity, and return only what needs a human decision. The analyst stops looking for the needle. They start the day already on what matters.
Why Sigalei organizes everything as regulatory objects.
- Product
- Registration
- Dossier
- Contract
- Plant
- Supplier
Organizing by objects changes the starting point. The regulation arrives connected to the object it affects. Analysis starts in the right place, with the object's history already loaded.
That's what lets the team keep answering in hours, not weeks, with 3,000 or 8,000 regulations on the radar.
Regulatory and Quality have never talked well. Now they must.
Regulatory Affairs and Quality were born in separate tools. IMS handling processes, regulatory monitoring handling text. They made sense in isolation.
The cost of that separation only became visible when volume grew. With separate tools, huge control spreadsheets emerged. Each spreadsheet became friction.
Sigalei is the single platform where both worlds share the same objects, the same flows, the same memory.
Each role in the area asks something different. Sigalei answers.
"What am I exposed to?"
Dashboard of risks and opportunities by area, registration and product. Defensibility in audit, strategic decisions based on data, not memory.
"Where is the team spending time?"
Flow visibility, action plan by owner, SLA per regulatory demand. Conversation with leadership about priority, not firefighting.
"What has changed since last time?"
Semantic search, version comparison, previous decision memory already attached. Starts analysis in the right place.
Traceability as a safety structure.
Aviation works this way: every incident becomes a lesson, every lesson becomes a new safety layer.
Regulatory areas can operate by the same principle, when the system allows. Recording every decision and its reason protects the organization. And protects the professional even more.
From cost center to business development area.
Without a system, the team becomes a firefighter. Each fire consumes the time for preventive action. Negative spiral.
With the operation in place, the area stops reacting. It anticipates opportunities, influences regulations in public consultation, sits at the strategic decision table.
Team firefighting, metrics trending down.
Preventive actions, strategic work, line trending up.
AI is in the game. Without governance, it only accelerates the error.
Generic LLM in a regulated environment produces false positives, false negatives, and no one can audit how it got there. In regulatory, that isn't AI. It's a liability.
Sigalei was built for high-reliability environments. AI specialized in regulatory text, with a precision pipeline, auditable trail of every inference, and customer-specific parameterization. Each deployment is parameterized to the objects, regulations and flows of your operation.
Specialized agents
Not raw LLM. Precision pipeline dedicated to regulatory text.
Agents trained for specific tasks: reading, classifying, comparing and synthesizing regulatory text.
Trail of every decision
Every AI inference is logged and reviewable. Defensible in audit.
Each analysis preserves source, prompt, model, version and human review. Reproducible months later.
SSO and profiles
SAML 2.0 and OpenID Connect, granular access profiles, immutable logs.
Integration with corporate IdP, role-based control, per-object scope and usage audit.
99.9% uptime
Daily backup. Infrastructure prepared for enterprise environments.
Continuous monitoring, tested recovery, contractual SLA for enterprise customers.
On-premise option
For customers with data residency requirements.
Dedicated install, data inside customer VPC, no transit through shared environments.
Custom
Parameterized onboarding and direct support. Not a generic ticket.
Contact with people who understand your sector, configuration adjustments and joint operational evolution.
More than an IMS. The platform that unites both worlds.
One tool per task created more fragmentation than control. Sigalei orchestrates monitoring, analysis, workflow, memory and evidence in a single system, with AI built for the regulatory context.
- Monitoring
- Analysis
- Workflow
- Memory
- Evidence
It's what the market was missing.
Built from a decade inside the problem. Backed by PIPE-FAPESP, with Phases 1 and 2 approved, with investment directed at applied AI research for high-precision regulatory text. Technology validated in real environments, with active customers in pharma, agribusiness and insurance.
Frederico Oliveira
Founder & CEO
Product engineer, regulated-industry background
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Want to see how Sigalei would solve this in your operation?
In a 30-minute conversation we show the product over your regulations, your flow, your objects. Not a generic demo.