More than 20 years inside Brazilian regulation.
From strategy to post-registration, we guide companies and products along the regulatory path, with nationwide reach since 2008.
- 20+years of practice
- 7regulated segments
- 12services
Pharmaceutical
- Regulators
- ANVISA, Local health authority, Federal Police, Army
Chemical & Sanitizers
- Regulators
- ANVISA, Local health authority, Federal Police, Army
Logistics Operations
- Regulators
- ANVISA, Local health authority, Federal Police, Army
Regulatory consultancy since 2008
Every link has its own requirements. Start with yours.
ANVISA authorizes companies by activity and regularizes products by risk. Choose your company’s position to see what is usually required and where Soluto works.
Medical Devices. You import into Brazil. Where we come in: Product Registration, GMP Certifications, Regulatory Consulting, Compulsory Certification & Foreign Markets
What is usually required
- AFE covering import activities, plus a local health licence
- Product regularized with ANVISA under a Brazilian company
- GMP Certification of the foreign manufacturer, when the class requires it
- ANVISA health clearance on import, according to the product
Requirements vary by product class and by activity. Framing your case starts with a conversation with our technical team.
From framing to post-registration.
Twelve service lines, organized by where your company stands: decide, enable and sustain.
Product Registration. Classification, dossier and notification or registration of domestic and imported products at ANVISA and MAPA.
Regulatory Consulting
Analysis, diagnosis, design, planning and execution, by a multidisciplinary team.
Scope
- Analysis
- Diagnosis
- Design
- Planning
- Execution
Strategic Regulatory Planning
A study of the product’s regulated market and a simulation of timelines and investment before the decision to invest.
Scope
- Authorized competition
- Who holds the market
- Entry alternatives
- Timelines and investment
- Implementation
Regulatory Due Diligence
Assessment of regulatory liability in acquisitions, mergers and investments.
Scope
- Licences and authorizations
- Authorized portfolio
- Good Practices and quality
- Regulatory liability
- Report
Corporate Restructuring & M&A
Planned transition of licences, registrations and certificates in mergers, acquisitions, demergers and spin-offs.
Scope
- Regulatory assets
- Operating strategy
- Transfers and changes
- Business continuity
- Integration
Company Licensing
AFE and AE at ANVISA, establishment registration with MAPA, and licences from health surveillance authorities, the Federal Police, the Army, environmental agencies and municipalities.
Scope
- ANVISA
- Health surveillance
- MAPA
- Controlled products
- Environment
- Municipality and councils
Product Registration
Classification, dossier and notification or registration of domestic and imported products at ANVISA and MAPA.
Scope
- Classification
- Regulatory pathway
- Technical dossier
- Imported products
- Filing and follow-up
GMP Certifications
Adaptation to Good Practices and preparation for the certification inspection.
Scope
- Pre-project audit
- Adaptation project
- Processes and procedures
- Internal audit
- Pre-inspection
- Certification inspection
- Maintenance
Compulsory Certification & Foreign Markets
Liaison with certification bodies under the INMETRO and ANATEL schemes and in other compulsory certifications.
Scope
- Regulatory mapping
- Medical equipment
- Telecommunications
- Technical documentation
- Liaison with the body
- Foreign markets
Regulatory Management
Deadlines, renewals and ancillary obligations for licences and registrations, followed continuously.
Scope
- Deadlines and obligations
- Renewals
- Controlled products
- Outsourcing and imports
- Document traceability
- On-demand advice
Post-Registration Activities
Changes, revalidations, registration certificates and Certificates of Free Sale after approval.
Scope
- Changes
- Revalidations
- Certificates
- Technical requests
- Technovigilance
Quality Management
Qualification and audit of suppliers and partners, with the records of each assessment.
Scope
- Requirements per partner
- Audits
- Monitoring
- Operating procedures
- Evidence for inspectors
In-Company Training
Tailored programmes on quality, operational routines and training policy.
Scope
- Quality management system
- Operational training
- Administrative training
- Training policy
Seven regulated sectors, each with its own language.
Every sector has its own rules, regularization routes and authorities. Knowing that language is what prevents rework.
See all segmentsCosmetics
Cosmetics, personal hygiene products and fragrances.
- Classification
- Formula review
- Documentation and claims
- Labelling
- Marketing
- Company and partners
Soluto was born inside the chain it serves.
Before we were Soluto, we were operations. In 2002, when ANVISA was still a young agency, we structured the Regulatory Affairs and Quality area of a company with branches in more than 15 states. Since then, we have followed every stage of Brazil’s regulatory evolution from inside the supply chain. That experience is where our way of working comes from.
In 2008, Soluto was born. From day one, with nationwide reach: company licensing across the country, product registration, quality process management and imports.
From 2011, these fronts came together as complete regulatory solutions, from framing to post-registration.
Why we exist
“We exist so that safe, effective, quality products reach people — and so that the companies that take them there can grow with the confidence of being compliant. To us, regulation is the path, not the obstacle.”
Four companies, one product journey.
Soluto Regulatórios is one of the four companies of Grupo Soluto. In the order of the regulatory journey: strategy, representation, technology and market.
Regulatory Strategy
Designs and leads regulatory strategy: company licensing, product regularization and quality management with ANVISA.
You are here
Marketing Authorization (MAH) & Compliance
Registration holder and legal representative of foreign manufacturers in Brazil, with pharmacovigilance and compliance.
Technology & Automation
The group’s technology layer: digital regulatory management, data and process automation.
Market Access
Qualification, registration and market access for generics and branded generics, with nationwide distribution to pharmacies, pharmacy chains, hospitals and public agencies.
Website coming soon
The holding company that integrates the four companies: regulatory, technological and commercial expertise for the healthcare market.
Your product’s path
- Planning
- Structuring
- Incorporation
- Licensing
- Regularization
- Registration
- Quality
- Distribution
- People
Entering the Brazilian market?
Tell us about your case: we design the entry route and lead every step in one place.
Design the entry routeThe destination is the same: a compliant operation. The route depends on strategy, investment and who will hold the registrations.
Option 1: Own operation
Your company incorporated in Brazil, with licences and registrations in its own name: the full route, from planning to distribution.
Option 2: Mergers, acquisitions or corporate restructuring
Entry by acquiring an existing operation or through corporate restructuring, with the deal’s regulatory strategy led by our team.
Option 3: Representation or outsourced registrations
Registrations are held by a qualified local distributor or by Ávita Care, a Grupo Soluto company that acts as registration holder and legal representative in Brazil.
Straight answers, before the first meeting.
What does a regulatory consultancy do?
It guides and manages a company’s relationship with regulators. At Soluto, that includes authorizing the company to operate (AFE and health licences), regularizing products with ANVISA (registration, notification or communication, according to risk), obtaining Good Practices certifications and keeping everything valid after approval.
See all servicesWhat is the difference between an AFE and a product registration?
The AFE authorizes the company; registration (or notification, depending on risk) regularizes each product. The AFE (Company Operating Authorization) covers activities such as manufacturing, importing, storing, distributing or transporting products under health surveillance. A company needs both: to be authorized and to have its products regularized.
Do medical devices need registration or notification?
It depends on the risk class. Under ANVISA’s current rule, class I and II medical devices are regularized by notification, and class III and IV devices by registration. Correct classification is the first step, because it defines the documentation and the route of the process.
View the Medical Devices sectorCan a foreign company register a product with ANVISA?
Not directly: the registration must be held by a company established in Brazil with an AFE. Foreign companies usually operate through an importer or a Brazilian registration holder. Within Grupo Soluto, Ávita Care acts as registration holder, while Soluto leads the strategy and the regulatory processes.
Explore the Market Entry pathHow long does it take to regularize a product?
It depends on the product category, the regularization route and ANVISA’s review queue, which changes over time. That is why we do not promise timelines that are not in our hands. What we do is build the process with the right documentation from the start, to reduce the risk of technical requests and rework.
Which sectors does Soluto serve?
Seven regulated sectors: pharmaceutical, medical devices, cosmetics, food, veterinary, chemical and sanitizing products, and logistics operations.
See all segmentsWhere is Soluto Regulatórios located?
In Vinhedo, São Paulo, at Rua Arnaldo Roque Brisque, 174, Vista Alegre. We serve companies from all over Brazil and abroad.
Tell us about your case. We map the route.
A first conversation to understand the product, the company and the market, and to outline the regulatory pathway and the steps of the process.
- Phone
- +55 19 3826-6800
- Address
- Rua Arnaldo Roque Brisque, 174 — Vista Alegre, Vinhedo/SP
- Hours
- Monday to Friday, 8 am to 5 pm (Brasília time)