Regulariza Certo
Registration Brazil
Regulatory Feasibility and Market Entry Consulting Strategy and Execution by Regulariza Certo
Regulatory Feasibility and Market Entry Consulting for Brazil
ANVISA and MAPA Compliance for Foreign Companies
Entering the Brazilian market is not only a commercial decision. It is a regulatory decision.
Through our proprietary Registration Brazil methodology, Regulariza Certo advises foreign companies on regulatory feasibility and full regulatory implementation for market entry in Brazil under ANVISA and the Brazilian Ministry of Agriculture.
Brazil is one of the most regulated markets in the world. Without prior regulatory validation, expansion plans are exposed to delays, rejected filings, financial losses, and operational disruption. Our role is to provide regulatory clarity before investment, structuring, and execution.
Supporting Foreign Companies Expanding into Brazil
We support manufacturers, exporters, investors, and corporate groups based outside Brazil that plan to enter or expand operations in the Brazilian market.
Our clients operate in regulated sectors including healthcare, pharmaceuticals, medical devices, cosmetics, food, agribusiness, veterinary products, and life sciences.
Our proprietary Registration Brazil methodology leads regulatory strategy and feasibility, while Regulariza Certo delivers the operational execution of licensing, registrations, and ongoing compliance required for market entry and continuityWhile
Why Brazil Requires Regulatory Feasibility Before a Business Plan
In Brazil, regulation defines viability.
ANVISA and the Ministry of Agriculture determine whether a product can legally be imported, manufactured, distributed, or commercialized. Product classification, approval pathways, labeling requirements, inspections, local representation, and post market obligations directly affect cost structure, timelines, and operational models.
A business plan developed without regulatory feasibility is not a strategy. It is exposure to legal and financial risk.
Regulatory Feasibility Report for Brazil Market Entry
Mandatory First Step
The Regulatory Feasibility Report is the mandatory first step before any regulatory filing, commercial agreement, or capital allocation related to Brazil.
Structured Assessment
It is a structured legal and technical assessment developed by Registration Brazil, with execution parameters validated by Regulariza Certo.
Market Entry Determination
Determining whether a product can legally enter the Brazilian market and under which regulatory conditions.
What the Regulatory Feasibility Report Delivers
Clear and actionable answers for decision makers from foreign companies:7
Product Admissibility
Is the product admissible under Brazilian law
Authority Identification
Which authority applies, ANVISA or the Ministry of Agriculture
Product Classification
How the product is classified for regulatory purposes
Required Documentation
Which licenses, registrations, and authorizations are required
Timeline Assessment
What regulatory timelines are realistic
Risk Analysis
What legal and operational risks may delay or block entry
Entry Models
Which market entry models are legally viable
This assessment allows companies to proceed with confidence or redesign strategy before committing resources.
ANVISA Regulatory Services for Foreign Companies
ANVISA regulates products related to health, life sciences, cosmetics, medical devices, pharmaceuticals, and personal care.
Once regulatory feasibility is confirmed, Regulariza Certo leads full ANVISA regulatory execution under the strategic guidance of Registration Brazil.
  • Company Operating Authorization, AFE
  • Health Surveillance Operating License
  • Product registration and notification
  • Medical device regulatory support
  • Pharmaceutical regulatory strategy
  • Cosmetics and personal care compliance
  • Labeling review and regulatory conformity
  • Regulatory representation before Brazilian authorities
Ministry of Agriculture Regulatory Services, MAPA
The Brazilian Ministry of Agriculture regulates food, agribusiness, veterinary products, animal feed, and agricultural inputs.
MAPA Registration
Through Regulariza Certo, we execute MAPA regulatory approvals aligned with the feasibility and market entry strategy defined by Registration Brazil.
Core Services
  • Company registration with MAPA
  • Product approval and registration
  • Import and commercialization authorization
  • Regulatory compliance for food and agribusiness products
  • Veterinary and feed product regulatory support
  • Technical documentation and labeling review
MAPA compliance directly impacts import authorization, logistics, and commercialization timelines.
Regulatory Strategy Beyond Approval
Regulatory approval in Brazil is not the final step.
Registration Brazil defines long term regulatory strategy, while Regulariza Certo provides ongoing compliance support to ensure operational security for foreign companies operating in Brazil.
Regulatory roadmap design
Inspection and audit readiness
Support during authority inspections
Post market regulatory obligations
Regulatory monitoring and updates
Strategic adjustments to regulatory changes
What Differentiates Our Approach
We do not offer fragmented regulatory services.
Registration Brazil
Delivers regulatory feasibility and strategic clarity
Regulariza Certo
Executes licensing, registrations, and compliance with precision
Together, we integrate feasibility, planning, and execution, identifying regulatory constraints early, mitigating legal risk, and supporting compliant and sustainable market entry.
Lucia Albanez, Brazilian Regulatory Attorney and Consultant
Lucia Albanez is a Brazilian regulatory attorney and consultant with over 20 years of experience in regulatory affairs, compliance, and market entry strategy under ANVISA and the Brazilian Ministry of Agriculture.
She developed the Registration Brazil proprietary methodology and founded Regulariza Certo, advising foreign companies on navigating Brazil’s regulatory environment and translating complex regulatory requirements into clear, business oriented guidance for executive and legal teams.”
Why Foreign Companies Trust Our Work
Deep Experience
Over 20 years of regulatory experience in Brazil
Specialized Expertise
Deep expertise in ANVISA and MAPA frameworks
Integrated Model
Integrated feasibility and execution model
Clear Communication
Clear communication aligned with international governance standards
Risk Mitigation
Strong focus on risk mitigation and predictability
Complete Support
End to end regulatory support through Regulariza Certo
Start with Regulatory Clarity
If Brazil is part of your expansion strategy, regulatory feasibility must come first.
Before building a business plan, allocating capital, or scaling operations, confirm whether market entry is legally viable and executable.
Schedule a regulatory feasibility discussion and define your real path to the Brazilian market with Registration Brazil and Regulariza Certo.
Contact
Regulariza Certo
WhatsApp
+55(11)94503-1517
Email
contact@registrationbrazil.com