Greetings from Freyr Brazil
Freyr is a global Regulatory leader providing services and solutions to life sciences companies. With a strong Regulatory knowledge base across 120+ countries, we support life sciences companies in their “local to global” journey.
ANVISA, the Regulatory Authority under the Health Ministry of Brazil, regulates drugs, medical devices, food supplements and, cosmetic products’ registration in the country.
At Freyr, we provide end-to-end Regulatory services ranging from Regulatory strategy, market intelligence, and local representation to post-approval product maintenance. We also offer next-generation Regulatory software solutions that streamline the entire drug registration process in Brazil, ensuring full compliance with the Brazil Drug Registration and Approval process and all Pharmaceutical Regulatory Affairs in Brazil requirements. This ensures a smooth and efficient path to Brazil market for your products.
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 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.
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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
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
Freyr Digital
An Innovative, Cloud-hosted, AI/ML enabled Regulatory Intelligence platform offering a complete spectrum of authoritative Regulatory Information
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Largest global ingredients repository and Regulatory database to support digitization of formulation assessment and real-time intelligence Know More
Freyr SPAR is one such RIM Solution that enables Life Science organizations to effectively manage the information right from tracking product registrations to generate statistical reports.
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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.
Know MoreOur Regional Expertise
We are a global firm and we have local expertise across the following countries.
