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Ávita Care

The strategic partner that eliminates regulatory and operational complexity, enabling your access to the Brazilian market with full compliance. As ANVISA registration holders, we conduct legal representation, import, storage, distribution and pharmacovigilance under a single CNPJ — with the backing of Grupo Soluto, a regulatory reference in Brazil since 2008.

ANVISA
CBPDA
GMP
21 CFR Part 11
LGPD
GDPR
GxP
ANVISA
CBPDA
GMP
21 CFR Part 11
LGPD
GDPR
GxP
02Solutions

Two operating modes, one single commitment

Legal Representation in Brazil

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 (RT)
  • 03Post-registration and license management
03Infrastructure

Enterprise, validated, traceable

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
  1. 01

    Soluto Regulatory Synergy

    Real-time regulatory intelligence and fast-track processes.

  2. 02

    Mirror Compliance

    We replicate your global standards with local precision.

  3. 03

    Expertise since 2008

    Strategic network established with ANVISA and regulatory bodies.

  4. 04

    Enterprise Infrastructure

    Hybrid Cloud and full LGPD/GDPR compliance.

05Complete Solution for Your Product in Brazil

8 Pillarsthat Eliminate Regulatory Complexity

From import to distribution: integrated operation, total traceability, and guaranteed compliance

01/ 08

ANVISA Registration Holder

We act as the legal responsible party before ANVISA and regulatory bodies — you focus on business, we manage compliance

02/ 08

Enterprise Hybrid Cloud Infrastructure

Azure + AWS with LGPD/GDPR compliance and validated GMP environments

03/ 08

Import to Distribution with Full Traceability

Unlimited licensing (LI/RADAR), controlled storage, and 24/7 validated cold chain

04/ 08

Quality Control

Infrastructure that meets the most rigorous pharmaceutical quality standards — a structure ready for your product

05/ 08

Excellence in Pharmacovigilance

System validated per current legislation, certified team, and continuous safety monitoring

06/ 08

Real-Time Regulatory Intelligence

Direct access to Soluto Regulatórios expertise — we anticipate regulatory changes and optimize processes

07/ 08

Mirror Compliance

We replicate exactly your global standards in the Brazilian market

08/ 08

Total Visibility with Real-Time Dashboards

Customized KPIs, automatic alerts, and instant regulatory performance reports

0199.9%
Guaranteed Uptime
0224 / 7
Continuous Monitoring
03100%
ANVISA Compliance
06Regulated Segments

5 ANVISA Segments,1 Infrastructure of Excellence

From pharmaceuticals to supplements: technical expertise, operational licenses, and qualified infrastructure for all product classes regulated by Health Surveillance

01

Pharmaceutical

Generic, similar, reference, and innovative drugs — all therapeutic classes with complete registration, import, and post-market management

Generics & Similar
02

Medical Devices

Equipment, implantables, in vitro diagnostics, and software as medical device — full compliance with RDC 185/2001 and international certifications

Class I to IV
03

Cosmetics and Hygiene Products

From personal hygiene to dermocosmetics — notification, registration, and post-market management with complete supply chain traceability

Grades 1 & 2
04

Sanitizers and Household Products

Hospital disinfectants, cleaning products, and household sanitizers — specialized storage and controlled chemical product management

Risks 1 & 2
05

Regulated Foods

Dietary supplements, functional foods, foods for special purposes, and novel foods — ANVISA/MAPA interface and nutritional labeling

Supplements
01100%
ANVISA Compliance
0217+
Years of Experience
0305
Regulated Segments
07Since 2018 — Soluto Group

Built onExpertise and Commitment

Ávita Care represents the natural evolution of a decade of regulatory leadership in Brazil — transforming complexity into opportunity since 2018

2018

Strategic Foundation

Born as Soluto Group's response to growing demands for a state-of-the-art operational structure accelerating go-to-market in Brazil.

Soluto Group
Go-to-Market

2020

Accelerated Expansion

Hybrid cloud infrastructure implemented, international clients established, high-complexity products, and quality control laboratory for complete tech transfer.

Hybrid Cloud
Tech Transfer

2024

New Soluto Headquarters

Inauguration of the new Soluto Group headquarters. Strategic expansion of operational capacity and infrastructure to support accelerated growth.

New HQ
Strategic Expansion

2025

Consolidated Leadership

7+ years of operation, high-volume import and distribution operations, presence in all 5 regulated segments, and Brazil's most complete ecosystem.

5 Segments
7+ Years
High Volume

2026

CBPDA Compliance

Good Distribution and Storage Practices requirements 100% compliance, including cold chain.

CBPDA
100% Compliance
Cold Chain
Mission, Vision and Values
CBPDAANVISA Certified
01100%
Compliance
02+8
Years of Operation
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 safe and agile access of products to the Brazilian market, ensuring full regulatory compliance and patient protection

II

Vision

To be recognized as the most reliable strategic Go-to-market partner in Latin America, establishing the standard of excellence in security, compliance, and operational innovation

III

Values

01

Unwavering Ethics

Integrity that Sustains Relationships

02

Security First

Total Protection in Every Process

03

Innovation with Purpose

Technology that Simplifies Compliance

04

Genuine Partnership

Shared and Sustainable Growth

05

Responsibility for Lives

Safe Access Transforms Health

06

Operational Excellence

Total Commitment to Quality

08Brazil's Only Complete Regulatory Ecosystem

4 Specialized Companies,1 Integrated Solution

Each company operates with individual excellence. But it's the complete synergy that transforms your entry into the Brazilian market from regulatory risk into proven competitive advantage

Sinergia
Integrated EcosystemExponential Results

While competitors offer disconnected pieces, Soluto Group delivers the complete working machine. From registration to shelf, you have a single point of contact and total accountability.

10Pharmacovigilance & Compliance

Patient SafetyFirst

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.

Importante

In medical emergencies, seek hospital care or call 192 (SAMU).

Relato de Evento Adverso

Precisa relatar um evento adverso?

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.

11Ready to Start?

Your Global Operation,Our Impeccable Local Execution

Schedule a strategic conversation with our specialists. No commitment, no cost — just an honest analysis of how we can accelerate your operation in Brazil with total compliance and zero headache.

  • 01Total Compliance
  • 02Fast-Track
  • 03Enterprise Security
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01Guaranteed response within 24 business hours
02Service in Portuguese, English, and Spanish
03Initial consultation at no cost
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