A company is built by its people.
By the relationships between them and by how everyone interacts with society. That is why, since 2008, Soluto Regulatórios has sought to win markets not only through technical competence, but above all through its values.
- Founded
- 2008
- Headquarters
- Vinhedo, SP, Brazil
- Group
- Grupo Soluto
- Legal name
- Soluto Consultoria e Assessoria em Assuntos Regulatórios Ltda
- CNPJ (tax ID)
- 09.579.745/0001-21
A regulatory One Stop Shop.
Soluto Regulatórios is part of Grupo Soluto, which brings together four companies along the product’s regulatory journey. Following the One Stop Shop concept, we offer integrated strategic and operational solutions that call for technical and regulatory competence.
We solve regulatory questions with a strategic view and protect our clients’ business through the compliance and regularization of their operations and products.
We develop technical, commercial and operational solutions covering different topics, areas and subjects driven by regulatory guidelines. The approach is systemic: each challenge is read in the context of the whole operation.
- Mission
- To structure safe and efficient regulatory, technical and operational solutions that help people and companies, making a difference in the dynamics of business and in society.
- Vision
- To be a reference in regulatory services, through technical knowledge and a commitment to the best corporate practices.
From operations to a strategic regulatory ecosystem.
Before it was Soluto, it was operations. Pharmacist Gisele Pimenta built the Regulatory Affairs and Quality area of a service company with branches in more than 15 states, bringing every unit into regular, licensed operation. She lived the import chain and the product registration cycle from the inside when ANVISA was still a young agency. She has followed every stage of Brazil’s regulatory evolution ever since.
In 2008, she conceived and founded Soluto. From day one, it worked nationwide, focused on licensing companies across the country, product registration, quality process management and imports.
From 2011, those fronts came together in ever more complete and structured regulatory solutions. It was the beginning of what was to come: an ecosystem able to serve companies from all over the world, protecting businesses and products and making their arrival in the Brazilian market possible.
Why we exist
Every regulated product carries a promise: to reach people safely, effectively and with quality. Regulation exists to guarantee that promise. We exist so that it is kept — without the business losing its way.
We work where science, regulation and operations meet. We translate requirements into decisions, decisions into processes, and processes into products that reach the market and stay there. We do it with technical rigor, transparency and a commitment to treating every case as unique.
We believe regulatory compliance is neither a cost nor an obstacle. It is what gives companies the confidence to grow and people the confidence to take care of their own health.
That is why we are here.
The guidelines behind our work.
The Soluto Regulatórios Quality Policy, in full.
Provide services grounded in the company’s core values.
Serve each client with respect for their individuality.
Act with integrity, compliance, ethics and legality.
Pursue continuous improvement in internal processes.
Use management, monitoring and control tools.
Build the organizational culture on loyalty, cooperation, transparency and commitment in internal and external relationships.
Train employees in new knowledge and skills.
Encourage the development of new attitudes and corporate competencies.
Be our clients’ first choice.
Be a reference in the Brazilian regulated market.
The values behind every project.
Work with usBusiness through people
Technical competence and a passion for service
Transparency builds trust
Continuous self-development
Ethical values and compliance are non-negotiable
In step with the regulated environment
Regulation is not bureaucracy
One of the four companies of Grupo Soluto.
In the order of the regulatory journey: strategy, representation, technology and market.
Discover Grupo Soluto
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
Want to meet the team?
Tell us about your regulatory project and we will set up a conversation with the people who will lead it.