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Pharmaceuticals Expertise

  • End-to-end Registration Support  
  • Authorized Local Agent Support  
  • Regulatory Affairs Consulting
  • Gap Analysis of the Dossier as per the ANVISA Regulatory Requirements
  • Query Support Management till Approval 
  • Pharmaceutical Product Compliance & Maintenance
  • Ad-hoc Regulatory Consultation
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Overview of the Brazilian
Regulatory Landscape

The Brazilian government believes that healthcare is a constitutional right, and hence, constantly update their Regulatory standards. This high-quality system has given a boost to the trade as well, making Brazil the largest pharmaceutical market in the LATAM region. Brazil dominates the pharma market not only in LATAM, but also on a global level. With a total share of 2.6%, Brazil holds the sixth position in the global largest pharma markets’ list. Experiencing a steady growth since a decade, the Brazilian pharma industry is constantly booming and is a major ground for investments and huge returns.

ANVISA is the drug Regulatory Authority under the Health Ministry in Brazil. ANVISA is a part of the Brazilian National Health System (SUS) as the coordinator of the Brazilian Health Regulatory System (SNVS). ANVISA’s role is to protect the population’s health by executing sanitary control of the production, marketing and use of products and services subject to health regulation, including related environments, processes, ingredients and technologies, as well as the control in ports, airports and borders.

 

Industries We Serve

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 related environment, processes, ingredients, and technologies, as well as the control in ports, airports, and borders.

  • End–to-end Registration Support  
  • Authorized Local Agent Support  
  • Regulatory Affairs Consulting
  • Strategic Regulatory Guidance during Product Development
  • Gap Analysis, Review, Compilation & Submission of the Dossier to the ANVISA
  • Interacting with the ANVISA
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Brazil is one of the fastest-growing markets for Medical Devices in the world. Brazil spends a lot on healthcare to boost the development of Medical Devices locally. It has established regulations in place and governs Medical Devices through National Health Surveillance Agency (ANVISA - Agência Nacional de Vigilância Sanitária) under the Ministry of Health. ANVISA follows strict regulations for Medical Device registration in Brazil.

  • Regulatory Intelligence in Brazil
  • Medical Device Classification and Grouping Strategy 
  • Brazilian Authorized Agent Representation
  • Interacting with the ANVISA
  • Strategic Regulatory Guidance during Product Development
  • Gap Analysis, Review, Compilation & Submission of the Dossier to the ANVISA
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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
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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
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About Freyr

Freyr is a leading, niche, full-service global Regulatory Solutions and Services Company supporting, Large, Medium and Small size global Life sciences companies, (Pharmaceutical | Generics | Medical Device | Biotechnology | Biosimilar | Consumer Healthcare | Cosmetics | Chemicals) in their entire Regulatory value-chain; ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions etc. to Post- Approval / Legacy Product Maintenance, Labeling, Artwork Change Management and other related functions.

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Our Regional Expertise

Being a Globally Local firm, we have our presence in the following countries, click to know more

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