POSITIONING

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.

Frederico Oliveira, Sigalei founder. Frederico Oliveira, Sigalei founder.
FROM OUR EXPERIENCE

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 CATEGORY

Regulatory monitoring had three generations. Sigalei is in the third.

Most tools on the market stopped at the second generation. Sigalei evolved its technology with a focus on the third.

01Generation 1

Regulatory in spreadsheets

You go to the official gazette's site, download the PDF, read everything, copy the acts, paste them into a document. Then you analyze which clients each act applies to, cut it up and assemble one document per client.

Fully manual process.

Most regulatory operations still start here today.

02Generation 2

Tool with built-in monitoring

Instead of the spreadsheet, you have software that pulls the acts in. You assess act by act, tag which client it goes to, and the tool assembles the report.

You still analyze every act, one by one.

It's what most tools on the market do today.

Sigalei is here
03Generation 3

Regulatory with AI Agents

You teach the agents which objects matter to each client and the nuances of each operation. When the agent captures an act, it already brings it organized by client with a suggested analysis. With every review, you teach the AI more.

You review instead of analyzing from scratch.

The only tool in the Brazilian regulatory market in this generation.

The difference between one generation and the next isn't just performance. It's the kind of work you still have to do manually.

THE DIFFERENTIATOR

Collecting and filtering became a commodity. Judgment didn't.

Today, any modern tool collects documents and filters them by keywords. That's the easy part to automate.

The work that still keeps you up at night in regulatory operations is what comes next:

01

Deciding whether an act is relevant to a specific client.

02

Identifying the nuances of each operation.

03

Organizing the delivery in the right format.

This used to be exclusively human work. Not anymore. Sigalei's technical differentiator is automating these decisions. The agents learn from your operation and execute with you reviewing, not doing it from scratch.

THE OPERATION

It's not a demo. It's been evolving for 10 years

Sigalei has operated for a decade in regulated environments. The agents described above run every day, on top of official sources, for regulatory teams.

Sigalei Data Sources

Breadth and depth in monitoring strategic data

12,456,278

Official Gazette Pages

7,843,617

Executive Acts

4,463,439

News

4,006,576

Regulations

3,646,168

Legislative Bills

2,891,400

Legislative & Executive Events

151,492

Social Media Posts

35M+

Total Integrated

HOW SIGALEI SEES THE REGULATORY OPERATION

Every regulatory area operates on three layers at the same time.

LAYER 1

Knows that it knows

Regulations mapped, processes under control.

LAYER 2

Knows that it doesn't know

Relevant sources not being read for lack of capacity.

LAYER 3

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.

SPREADSHEETS DON'T SOLVE IT

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.

HOW INFORMATION IS ORGANIZED

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.

FOR THOSE IN THE OPERATION

Each role in the area asks something different. Sigalei answers.

DIRECTOR

"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.

MANAGER

"Where is the team spending time?"

Flow visibility, action plan by owner, SLA per regulatory demand. Conversation with leadership about priority, not firefighting.

SPECIALIST ANALYST

"What has changed since last time?"

Semantic search, version comparison, previous decision memory already attached. Starts analysis in the right place.

INSPIRED BY HOW AVIATION WORKS

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 REACTIVE TO STRATEGIC

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.

AI, BUT WITH GOVERNANCE

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.

ARCHITECTURE

Specialized agents

Not raw LLM. Precision pipeline dedicated to regulatory text.

Agents trained for specific tasks: reading, classifying, comparing and synthesizing regulatory text.

AUDITABILITY

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.

ACCESS

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.

AVAILABILITY

99.9% uptime

Daily backup. Infrastructure prepared for enterprise environments.

Continuous monitoring, tested recovery, contractual SLA for enterprise customers.

DEPLOYMENT

On-premise option

For customers with data residency requirements.

Dedicated install, data inside customer VPC, no transit through shared environments.

SUPPORT

Custom

Parameterized onboarding and direct support. Not a generic ticket.

Contact with people who understand your sector, configuration adjustments and joint operational evolution.

CONCLUSION

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.

BACKING

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.

PIPE-FAPESP · Fases 1 e 2 aprovadas Pesquisa aplicada de IA para texto regulatório de alta precisão.
FOUNDING TEAM
Frederico Oliveira

Frederico Oliveira

Founder & CEO

Product engineer, regulated-industry background

Danilo Oliveira

Danilo Oliveira

Founder & CTO

Computer Engineer and Data Scientist

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.