Your Secure Gatewayto the Brazilian Regulated Market.
ANVISA registration holding, legal representation, importation, warehousing, distribution, pharmacovigilance and customer service — under one CNPJ.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.
01Legal representation as registration holder
02Dedicated technical manager
03Post-registration, license and quality management
Integrated Operational Management
From import to distribution, with excellence infrastructure, validated pharmacovigilance, and total traceability. Your global operation, our impeccable local execution.
01Own import and qualified storage
0221 CFR Part 11 validated pharmacovigilance
03Real-time customized dashboards
03Infrastructure
Enterprise, custom solution
World-class hybrid infrastructure with certified security, compliance and quality.
Enterprise
Cloud01
Azure · AWS
Compliance02
LGPD · GDPR
Environments03
GMP · Cold Chain
Security04
E2E Encryption
04Advantages
What makes us unique in the Brazilian market
Advantages
01
Expertise since 2008
Established institutional relationships with ANVISA and regulatory bodies.
02
Integration with Soluto Regulatórios
Real-time regulatory intelligence and anticipation of regulatory changes.
03
Mirror Compliance
We replicate your global standards with local precision.
04
Enterprise Infrastructure
Hybrid Cloud and full LGPD/GDPR compliance.
05What We Do
8 Pillarsof our regulatory structure
The pillars that sustain our complete regulatory structure in Brazil.
01
ANVISA Marketing Authorization Holder
Marketing authorization holder under our own CNPJ, with legal representation before regulatory bodies and a dedicated Technical Manager throughout post-registration.
02
Pharmacovigilance Excellence
21 CFR Part 11 validated system, certified team, global signal monitoring, and 24/7 ANVISA reporting.
03
Quality Control
In-house quality control laboratory, supplier audits, CAPA management, and process validation under Good Practices.
04
Import to Distribution with Full Traceability
Import licensing, qualified storage, and nationwide distribution under a 24/7 validated cold chain, with end-to-end traceability.
05
Enterprise Hybrid Cloud Infrastructure
Enterprise environment with hybrid-cloud data, Good Practices-validated systems, and full operational traceability.
06
Real-Time Regulatory Intelligence
Continuous normative monitoring via Soluto Regulatórios, anticipating regulatory processes when applicable.
07
Mirror Compliance
Replication of your global standards in Brazil. Harmonization that aligns HQ and local operations.
08
Full Visibility with Real-Time Dashboards
Dashboards with customized KPIs, automatic alerts, and instant reports — full visibility for strategic decisions.
01
0199.9%
Guaranteed Uptime
02
0224/7
Continuous Monitoring
03
03100%
ANVISA Compliance
06Where We Operate
5 ANVISA Segments,1 Structure of Excellence
Present in 100% of all ANVISA-regulated segments.
Pharmaceuticals
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.
All therapeutic classes
Medical Devices
Medical devices across the four risk classes (I through IV), under notification and registration regimes. Full lifecycle management, with Inmetro and Anatel interface.
Class I to IV
Cosmetics
Personal hygiene to dermocosmetics. Notification, registration, and post-market with end-to-end traceability.
Grades 1 & 2
Sanitizers
Hospital disinfectants and household products. Specialized storage and controlled chemical management.
Risks 1 & 2
Regulated Foods
Supplements, functional foods, special purpose, and novel foods. ANVISA/MAPA interface management.
Supplements · Functional · Novel Foods
01
01100%
ANVISA Compliance
02
0217+
Years of Experience
03
0305
Regulated Segments
07Since 2018 — Soluto Group
Built onExpertise and Commitment
Ávita Care represents more than a decade of regulatory leadership by Grupo Soluto, in our own operation since 2018.
2008
2008
Founding of Soluto Regulatórios
Already with the vision of becoming the most complete regulatory consultancy in the market, delivering technical excellence.
Soluto Group
Technical Excellence
2018
2018
Founding of Ávita Care
Born as Soluto Group's response to growing demand for a complete operational structure for the entry of regulated products into the Brazilian market.
Soluto Group
Own Operation
2020
2020
Structured Expansion
Hybrid cloud infrastructure implemented, international clients established, high-complexity products, and quality control laboratory for complete tech transfer.
Hybrid Cloud
Tech Transfer
2024
2024
New Soluto Headquarters
Inauguration of the new Soluto Group headquarters. Strategic expansion of operational capacity and infrastructure to support the expansion of the operation.
New HQ
Strategic Expansion
2025
2025
Consolidated Leadership
In own operation since 2018, high-volume import and distribution, presence in all 5 regulated segments, and Brazil's most complete ecosystem.
5 Segments
Since 2018
High Volume
2026
2026
CBPDA Requirements Met
Good Distribution and Storage Practices (CBPDA) — requirements fully met, including cold chain; certification in progress.
CBPDA
Requirements Met
Cold Chain
Own Infrastructure
Our own physical and operational infrastructure, built to support your regulated operation in Brazil.
01
01100%
Compliance
02
022018
In Operation Since
03
0305
Regulated Segments
What Drives Us
“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.”
I
Mission
Enable access of products to the Brazilian market with full regulatory security and patient protection.
II
Vision
To be recognized as the most reliable regulatory structure in Latin America, establishing the standard of excellence in security, compliance, and operational innovation.
III
How we act
The principles of our Quality Policy that guide every decision.
01
Structure before speed
We don't rush launches without regulatory, logistical, and operational maturity.
02
Partnership, not brokerage
We are the manufacturer's extension in Brazil — not a broker.
03
Commitment after entry
We sustain the product in the market with continuous technical, regulatory, and logistical support.
04
Own infrastructure as the foundation
We invest in storage, temperature control, and traceability before expanding the portfolio.
05
No shortcuts
We never compromise compliance or quality for the sake of deadlines or volume.
06
Responsibility is not delegated
When we contract transport or services, we remain fully accountable for delivery.
07
Growth with substance
We scale as the structure can support. Solidity before size.
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.
Adverse Event Report
Need to report an adverse event?
Describe what happened and provide contact details for follow-up. Your report will be forwarded to our pharmacovigilance team for assessment.
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.
