Strategic Regulatory Partner for Success in Brazil

Greetings from

Pharma Wizard Brazil

Pharma Wizard is a global Regulatory leader offering comprehensive services and solutions to life sciences companies. With deep Regulatory expertise across 120+ countries, we support organizations in their “local to global” market expansion journey.

In Brazil, the National Health Surveillance Agency (ANVISA), under the Ministry of Health, regulates the registration of drugs, medical devices, food supplements, and cosmetic products.

At Pharma Wizard, we deliver end-to-end Regulatory services, from strategic consulting, market intelligence, and local representation to post-approval product lifecycle management. Our next-generation Regulatory software solutions streamline the entire drug registration process in Brazil, ensuring compliance with ANVISA requirements and facilitating faster market entry.

Industries We Serve in Argentina

ANVISA is the drug Regulatory Authority in Brazil under the Health Ministry. The ANVISA is an autarchy linked to the Ministry of Health, part of the Brazilian National Health System (SUS) as the coordinator of the Brazilian Health Regulatory System (SNVS), present throughout the national territory. ANVISA’s role is to promote the protection of the population’s health by executing sanitary control of the production, marketing and use of products, and services subject to health regulation, including Brazil drug regulatory requirements related environment, processes, ingredients, and technologies, as well as the control in ports, airports, and borders.

End–to-end Support for Brazil Drug Registration and Approval Process.
Authorized Local Agent Support
Regulatory Affairs Consulting for Brazil Market.
Strategic Regulatory Guidance during Product Development
Gap Analysis, Review, Compilation & Submission of the Dossier to the ANVISA
Interacting with the ANVISA

Brazil is one of the biggest countries in South America. It is one of the fastest growing markets for Medical Devices in the world. Brazil spends hugely on healthcare boosting the Medical Devices development locally. The country has established regulations in place, and it governs Medical Devices through National Health Surveillance Agency (ANVISA – Agência Nacional de Vigilância Sanitária) under the Ministry of Health. Foreign manufacturers must appoint a Brazilian Registration Holder (BRH) to assist them with the Brazil medical device registration process

Brazil is the only country in Latin America to have a well-defined legislation for functional and health claims for the nutrient and non-nutrient components. The Brazilian Regulatory framework for these components has been developed by the National Health Surveillance Agency (ANVISA – Agência Nacional de Vigilância Sanitária) based on safety and efficacy of the products. These products are defined as Food & Food Supplements. ANVISA follows strict regulations for Food Supplement registration in Brazil. The Food supplement category was created in 2018 to guarantee access to safe and quality products for the population. The term “Supplement” applies only to minerals, vitamins, or a combination of both. ANVISA has established guidelines for these products as per the scientific advice of the committee – Technical and Scientific Committee on Functional Food and Novel Ingredients (CTCAF). • Food Product Classification • Formula Review/Ingredients Assessment • Food Label and Claims Review • Compliance as per the New Labeling Regulation • Claims Consultation and Substantiation • Interacting with the ANVISA

Food Product Classification
Formula Review/Ingredients Assessment
Food Label and Claims Review
Compliance as per the New Labeling Regulation
Claims Consultation and Substantiation
Interacting with the ANVISA

Cosmetics market in Brazil is anticipated to grow at significant level due to changing lifestyle and growing demand for skin-care. In addition to this, increasing consumer awareness regarding skin-care aids the market growth in Brazil. Cosmetics must be subjected to cosmetics notification or Cosmetic Product registration with the Agencia Nacional de Vigilancia Sanitaria (ANVISA), which regulates the Cosmetics registration, production, import, and trade of cosmetics in Brazil.

Cosmetics Classification
Cosmetic Product Formulation/Cosmetics Ingredient Review
Cosmetic Claims Review
Dossier Compilation, Review & Submission
Interactions with the ANVISA

Pharma Wizard Expertise

End-to-end support for Drug Registration in Brazil
Authorized Local Agent Representation
Regulatory Affairs Consulting
Dossier Gap Analysis as per ANVISA Guidelines
Query Response Management through to Final Approval
Ongoing Pharmaceutical Product Compliance & Maintenance
Ad-hoc Regulatory Consultation
Comprehensive support for full compliance with Brazil's drug regulatory framework and ANVISA guidelines—from submission through approval

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Food & Food Supplements Product Services

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