Regulatory Consulting
For regulatory questions that do not fit in a single filing: a multidisciplinary team analyses the scenario, diagnoses it and carries the solution through to execution.
- Company stage
- Decide
How the consulting works.
Five stages, always in this order. The solution is designed for the scenario diagnosed for each client.
Analysis
Understanding the need: product, operation, existing documents and the business goal.
- Technical interviews
- Document review
Diagnosis
What is compliant, what is missing and what is a risk, in order of priority.
- Gaps and risks
- Priorities
Design
The solution designed for the case, with the technical and regulatory alternatives assessed.
- Alternatives assessed
- Recommended solution
Planning
Activities, owners, deadlines and filings in a single schedule.
- Schedule
- Defined owners
Execution
We carry out the work, deal with the agency and keep the client informed at every stage.
- Filings and follow-up
- Agency interaction
Other services for this stage.
- Strategic Regulatory PlanningDecideA study of the product’s regulated market and a simulation of timelines and investment before the decision to invest.
- 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.
When should I use a regulatory consultancy instead of filing on my own?
When the classification of the product is not obvious, when several authorities are involved or when a filing error costs time to market. The consultancy reads the scenario, defines the pathway and runs the process through to the decision, with a team that follows the changing rules.
How does the work start?
With a diagnosis: understanding the product, the operation and the stage the company is at. From there come the strategy and a plan with owners and steps. Execution runs from documentation to following the review and the requests for information.
Do you serve foreign companies?
Yes. We serve manufacturers and brands from abroad that want to enter Brazil, including defining the entry model and setting up the registration holder in the country, together with the companies of Grupo Soluto.
Last updated: October 2026.
A regulatory problem with no clear path?
Describe the scenario. The first conversation already points to the diagnosis needed and who on the team leads the case.