We act as the ANVISA marketing authorization holder, handling legal representation, import, storage, distribution, pharmacovigilance, and SAC under a single CNPJ. Your entry into the Brazilian market operates under a complete regulatory structure with clearly defined technical accountability — backed by Grupo Soluto, a regulatory benchmark in the country since 2008.
ANVISA registration ownership, full legal representation, and technical responsibility. We are your registration holder and responsible party before all regulatory bodies.
World-class hybrid infrastructure with certified security, compliance and quality.
EnterpriseAzure · AWS
LGPD · GDPR
GMP · Cold Chain
E2E Encryption
Established institutional relationships with ANVISA and regulatory bodies.
Real-time regulatory intelligence and anticipation of regulatory changes.
We replicate your global standards with local precision.
Hybrid Cloud and full LGPD/GDPR compliance.
The pillars that sustain our complete regulatory structure in Brazil.
Marketing authorization holder under our own CNPJ, with legal representation before regulatory bodies and a dedicated Technical Manager throughout post-registration.
21 CFR Part 11 validated system, certified team, global signal monitoring, and 24/7 ANVISA reporting.
In-house quality control laboratory, supplier audits, CAPA management, and process validation under Good Practices.
Import licensing, qualified storage, and nationwide distribution under a 24/7 validated cold chain, with end-to-end traceability.
Enterprise environment with hybrid-cloud data, Good Practices-validated systems, and full operational traceability.
Continuous normative monitoring via Soluto Regulatórios, anticipating regulatory processes when applicable.
Replication of your global standards in Brazil. Harmonization that aligns HQ and local operations.
Dashboards with customized KPIs, automatic alerts, and instant reports — full visibility for strategic decisions.
Present in 100% of all ANVISA-regulated segments.
Innovative, generic, similar, and new drugs, as well as biologicals, herbal, specific, and dynamized medicines. Complete management of registration, import, and post-registration with ANVISA.
Medical devices across the four risk classes (I through IV), under notification and registration regimes. Full lifecycle management, with Inmetro and Anatel interface.
Personal hygiene to dermocosmetics. Notification, registration, and post-market with end-to-end traceability.
Hospital disinfectants and household products. Specialized storage and controlled chemical management.
Supplements, functional foods, special purpose, and novel foods. ANVISA/MAPA interface management.
Ávita Care represents more than a decade of regulatory leadership by Grupo Soluto, in our own operation since 2018.
Already with the vision of becoming the most complete regulatory consultancy in the market, delivering technical excellence.
Born as Soluto Group's response to growing demand for a complete operational structure for the entry of regulated products into the Brazilian market.
Hybrid cloud infrastructure implemented, international clients established, high-complexity products, and quality control laboratory for complete tech transfer.
Inauguration of the new Soluto Group headquarters. Strategic expansion of operational capacity and infrastructure to support the expansion of the operation.
In own operation since 2018, high-volume import and distribution, presence in all 5 regulated segments, and Brazil's most complete ecosystem.
Good Distribution and Storage Practices (CBPDA) — requirements fully met, including cold chain; certification in progress.
Our own physical and operational infrastructure, built to support your regulated operation in Brazil.
“What drives us is believing that through our services we develop solutions that make a difference in our clients' and commercial partners' businesses, in people's lives, and in society as a whole.”
Enable access of products to the Brazilian market with full regulatory security and patient protection.
To be recognized as the most reliable regulatory structure in Latin America, establishing the standard of excellence in security, compliance, and operational innovation.
The principles of our Quality Policy that guide every decision.
We don't rush launches without regulatory, logistical, and operational maturity.
We are the manufacturer's extension in Brazil — not a broker.
We sustain the product in the market with continuous technical, regulatory, and logistical support.
We invest in storage, temperature control, and traceability before expanding the portfolio.
We never compromise compliance or quality for the sake of deadlines or volume.
When we contract transport or services, we remain fully accountable for delivery.
We scale as the structure can support. Solidity before size.
Each company operates with excellence in its specialty. It's the integration between them that converts the regulatory risk of your entry into Brazil into a controlled and predictable operation.
While competitors offer disconnected pieces, Soluto Group operates the complete structure, from registration to distribution. You have a single point of contact and total accountability.
Our dedicated team continuously monitors the safety of all products under our responsibility, strictly complying with current legislation and international standards. Report adverse events with complete confidentiality through multiple channels — your communication protects patients and strengthens regulatory safety.
In medical emergencies, seek hospital care or call 192 (SAMU).
Preencha o formulário de forma segura e anônima se preferir. Nossa equipe de farmacovigilância inicia a investigação em até 24 horas úteis e notifica a ANVISA quando aplicável.
Schedule a strategic conversation with our regulatory team. A technical analysis of how to structure your operation in Brazil, with full compliance and responsibility defined at every step.
