Clarity in aComplexWorld
We transform regulatory complexity into clear pathways for your business. Technical expertise and strategic vision so you can reach the market with safety and compliance.
Our SolutionsRegulatory One Stop Shop.
Technical, strategic and operational services integrated into the regulatory process — from planning to final approval.
Regulatory Management
We manage your product's entire regulatory lifecycle: from feasibility analysis to registration maintenance. We act as an extension of your team before ANVISA and other regulatory bodies.
- Product Regularization
- Post-Registration Activities
- Company Licensing
- Specialized Regulatory Consulting
Strategy & Planning
We design your regulatory pathway before you invest. Scenario analysis, risk mapping and strategic roadmap for safe entry into the Brazilian market.
- Strategic Regulatory Planning
- Regulatory Due Diligence
- Corporate Restructuring & M&A
- OCP & External Market Interface
Quality & Compliance
We implement and maintain quality management systems aligned with Brazilian and international regulatory requirements. From GMP certification to team training.
- Quality Management
- GMP & Certifications
- Regulatory Compliance
- In-Company Training & Development
Industry Segments
Specialized regulatory expertise for every market.
Pharmaceutical
Drugs, pharmaceutical inputs and medical gases. Registration, post-registration and renewals with ANVISA.
Medical Devices
Medical devices, equipment and healthcare materials. Classification, registration and certification.
Cosmetics
Cosmetics, perfumery and personal care. Notification, registration and technical dossiers per current regulations.
Food & Beverage
Foods, supplements and beverages. Registration, registration exemption and functional claims.
Veterinary
Veterinary products and agrochemicals. Interface with MAPA and specific registration processes.
Chemical & Sanitizers
Sanitizers, household chemicals and chemical products. Notification, registration and safety data sheets.
Logistics Operations
Storage and distribution of regulated products. Licensing, permits and good distribution practices.
What drives us is the conviction that our services create solutions that make a real difference — in our clients' businesses, in people's lives, and across society.
Regulatory Expertise
Complete mastery of ANVISA regulations, RDCs, INs, and regulatory bodies. Over 500 approved registrations with a 98% success rate — knowledge that transforms regulation into real competitive advantage.
Strategic Vision
Every regulatory process is designed with business intelligence. We anticipate scenarios, map risks, and build roadmaps that accelerate your entry into the Brazilian market with confidence.
Process Agility
Processes optimized over 17 years of experience that drastically reduce time-to-market. We eliminate rework, prevent requirements, and accelerate approvals with regulatory bodies.
Dedicated Support
A collaborative technical team driven by self-development and excellence in results. We accompany every stage of your project as an extension of your team.
Tailored Solutions
Every project is unique. We design personalized regulatory strategies that adapt to your business model, size, and market objectives.
The rigor of regulation.
The fluidity of business.
Soluto is not just a regulatory consultancy; we are architects of viability. In an increasingly dense regulatory environment, passive compliance is a risk. Our approach is proactive and strategic.
We invert traditional logic: we don't start with "no", but with "how". We deeply understand our clients' technology and business models to design regulatory structures that protect without suffocating.
Regulation should be the foundation of innovation, not its ceiling.
Mission
To enable regulated businesses through strategic intelligence, transforming the healthcare sector's regulatory complexity into sustainable competitive advantage for our clients.
Vision
To be Brazil's benchmark in strategic regulatory consulting, recognized for technical excellence, process agility, and a proven ability to deliver concrete results.
PART OF SOMETHING
BIGGER.
As a Grupo Soluto company, we integrate a complete ecosystem of solutions for the regulated healthcare sector in Brazil.
Strategic Distribution
Cona Health Care
Distribution of high-quality products and innovation in human health. Specialized logistics and service excellence.
Technology & Automation
PIXOOM
Integrated visual management platform. Intelligent automation and custom digital transformation for the healthcare sector.
Regulatory Strategy
Soluto Regulatory
Specialized consultancy in regulatory affairs. Expertise in registrations, certifications, and market strategies.
Representation & Compliance
AvitaCare
Legal representation of foreign manufacturers in Brazil. Compliance management and pharmacovigilance.
Grupo Soluto
Holding
The ecosystem integrator. A holding company uniting regulatory, technological, and commercial expertise for the healthcare market.
BEYOND
REGULATION.
We are not just consultants.
We are the regulatory architects connecting global innovation to the Brazilian healthcare market. Every strategy we design carries the responsibility of enabling businesses that impact lives.
"Intelligence that enables. Strategy that sustains."
We were born from the vision that regulation doesn't have to be a barrier. With over 17 years of experience, we have built a track record based on concrete results and lasting relationships of trust.
Where others see complexity, we see opportunity. Behind every approved registration is a product that can transform the health of thousands. This awareness drives every strategy we develop.
Applied Intelligence
We combine deep technical knowledge with strategic business vision. Every recommendation is grounded in data and proven experience.
Quiet Excellence
We don't promise shortcuts. We deliver solid processes, on time, with quality that speaks for itself. The extraordinary lies in consistency.
Measurable Impact
Every regulatory strategy we develop has clear success metrics. Concrete results, not just reports.
Our Manifesto
We believe the Brazilian healthcare market deserves efficient access to the world's best innovations. We believe regulatory expertise and agility can coexist. We believe lasting relationships are built on results, not promises. That is why we exist.