Your company in Brazil, from planning to distribution.
A foreign company cannot obtain marketing authorization for a product directly from ANVISA. The registration holder (detentor, in Portuguese) must be a company incorporated in Brazil, which is legally responsible for the product. We lead the set-up in one place, from regulatory work to operations: this is Grupo Soluto’s One Stop Shop model.
- Who it is for
- Foreign companies that will manufacture, import or distribute regulated products in Brazil.
- Model
- One Stop Shop: one route, three ways in.
Three ways in.
The destination is the same: a compliant operation. The route depends on strategy, investment and who will hold the registrations.
One route, from plan to distribution.
The set-up follows a single route. Along the way, two exits shorten the path when the strategy calls for it; the full route ends with your own operation up and running.
Regulatory planning
Portfolio classification and regulatory entry strategy.
Commercial structuring
Business model and sales channels in Brazil.
Operational structuring
Operation and supply chain design.
Business start-up
The plan for the new company in Brazil.
Company incorporation
The legal entity incorporated in Brazil.
Licensing
Licences and authorizations from the competent regulatory agencies.
Product registration
Registration or notification of the portfolio, according to its classification.
Quality management and good practices
Quality system and good operational practices.
Product import
Import within regulatory requirements.
Product distribution
The product reaches the Brazilian market.
Beyond the regulatory.
Business fronts that complete the market entry, from feasibility studies to taxation.
Strategy and management
Market strategy and business development
Structuring and managing businesses in Brazil
Presence and distribution
Product representation in Brazil
Product import and distribution
Distributor mapping and qualification
Feasibility and costs
Technical and commercial feasibility studies
Pricing of imported products
Operating cost assessment
Tax studies and strategies:
we build the rationale, with specialist partners on the project
Entering the Brazilian market?
Tell us about your case: we design the entry route and lead every step in one place.