Strategic Regulatory Planning
Before the decision to invest, a study of the regulated market for your product: who is already authorized, under which conditions, through which channels, and which path makes sense for your company to enter.
- Company stage
- Decide
From the study to implementation.
Planning starts from public registrations and the real market for the product, according to each client’s needs.
Authorized competition
Competing and similar products already authorized in Brazil and the conditions approved for each one.
- Similar authorized products
- Contraindications and warnings
- Approved directions for use
Who holds the market
Manufacturers, registration holders and distributors, with their geographic reach and buying public.
- Manufacturers and holders
- Distributors by region
- Buying public
Entry alternatives
The possible models to start operating and the licences each one requires.
- Operating models
- Licences per model
- Side-by-side comparison
Timelines and investment
A simulation of the regulatory time and investment of each alternative, so the decision is made with data.
- Timeline simulation
- Investment estimate
- Feasibility analysis
Implementation
Structured execution with project management, liaison with the parties involved and disciplined communication with the client.
- Project management
- Liaison with the parties involved
- Communication with the client
Foreign company?Explore the Market Entry path
Other services for this stage.
- Regulatory ConsultingDecideAnalysis, diagnosis, design, planning and execution, by a multidisciplinary team.
- Regulatory Due DiligenceDecideAssessment of regulatory liability in acquisitions, mergers and investments.
- Corporate Restructuring & M&ADecidePlanned transition of licences, registrations and certificates in mergers, acquisitions, demergers and spin-offs.
Common questions before you start.
What does regulatory planning deliver before the investment?
A map of the path: the likely classification of the product, the regulatory pathway (notification or registration), the authorizations the company must hold, the authorities involved and the order of steps with their dependencies, so that time and investment are sized before contracting a factory, imports or distribution.
Is it worth planning before choosing a partner in Brazil?
Yes. The choice between your own operation, acquiring an already licensed company or an outsourced holder changes which licences must exist and in whose name the registrations are kept. Deciding this first avoids transferring ownership later.
Does the plan include an estimated approval time?
It includes the steps and the dependencies between them, based on the rules in force, but it does not promise authority review times. At ANVISA, review queues follow the order of entry and can be looked up by area and by queue. We work so that the filing goes in complete and does not receive avoidable requests for information.
Last updated: October 2026.
Investing in a regulated product?
Before the first filing, we show the regulated market for the product and the entry alternatives with estimated timelines.