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Brazil

Life Sciences Compliance Services in Brazil

Brazil-based consulting company offering regulatory support, product approval, and compliance services for life sciences firms. Simplifying your regulatory journey in Brazil, from product conceptualization to market entry and ongoing compliance maintenance.

Brazil Artixio – Regulatory affairs consulting expert
Brazil

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Approval and Compliance Strategy with ANVISA

Artixio is a trusted global partner providing seamless regulatory services for Life Sciences products in Brazil. Our well-experienced staff is customer-focused and provides tailored regulatory solutions for navigating through the stringent regulatory requirements of ANVISA in Brazil. We assure timely compliance and offer continued support for sustaining your product in the Brazilian market.

Regulatory Authorities in Brazil

ANVISA

  • ANVISA is the main authority responsible for the smooth regulation of pharmaceuticals, biologics, medical devices, cosmetics, and wellness products in Brazil.
  • It oversees all the regulations for the above-mentioned Life Sciences products, such as production, distribution, import-export services, marketing, and post-marketing surveillance.
  • ANVISA, in association with CONEP, regulates the clinical trials in Brazil.
  • INMETRO provides certification for medical devices are ensures the product safety in association with ANVISA in Brazil.

MAPA

  • MAPA is known for the regulation of veterinary products, animal biologics, and food for animal use in Brazil.
  • These veterinary products are registered and marketed under the guidelines of MAPA in Brazil.

Your Life Sciences Regulatory Partner in Brazil

The Artixio team in Brazil has proven experience in successfully helping hundreds of products register and launch products while also ensuring post-market maintenance of compliance. Our local expertise in Brazil with proven experience of 15-30 years aims to ensure timely compliance of your Life Sciences product by streamlining the regulatory pathway. Our customer-focused team provides tailored solutions for regulatory compliance with ANVISA in Brazil.

Our Services

Regulatory advisory consultant – Artixio
Regulatory Affairs
Compliance and regulatory consulting – Artixio
Product Registration Services Artixio
Product Registration
Compliance and regulatory consulting – Artixio
Global regulatory advisory services – Artixio
Market Access
Compliance and regulatory consulting – Artixio
Regulatory compliance consulting services
IND (Investigational New Drug)
Compliance and regulatory consulting – Artixio
New Drug Application Regulatory
NDA (New Drug Application)
Compliance and regulatory consulting – Artixio
Regulatory operations consulting services Artixio
Regulatory Operations
Compliance and regulatory consulting – Artixio
Technical Writing in Regulatory Artixio
Technical Writing
Compliance and regulatory consulting – Artixio
Regulatory Strategy Services Artixio
Regulatory Strategy
Compliance and regulatory consulting – Artixio
Life sciences consulting services Artixio
Market Access
Compliance and regulatory consulting – Artixio
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Why Trust Artixio with Your Regulatory Journey in Brazil?

Compliance consulting services company
Customized regulatory strategy for compliance with ambiguous ANVISA regulations
Compliance consulting services company
Tech-enabled team with a compliance-oriented mindset in Brazil
Compliance consulting services company
Industry recognized team (CPHI Pharma Awards 2024)
Compliance consulting services company
Local expertise with 15-20 years of experience in successfully registering and maintaining 2000+ licenses
Compliance consulting services company
Direct access to in-house ANVISA regulatory liaisons
Compliance consulting services company
KPI based, continual process excellence   
Compliance consulting services company
End-to-end support from product concept/prototype development, approval, and post-approval.
Compliance consulting services company
ISO 9001:2015 certified quality assured team
Compliance consulting services company
Regulatory intelligence-driven, experience-based, tech-assisted for expedited market entry
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FAQs

1. How long does ANVISA take for the approval of a LifeSciences product in ANVISA?
The time for approval of pharmaceuticals depends on the type of Life Sciences product and its complexity. Such as for pharmaceuticals, it takes about 12-18 months, and for medical devices, it may take anywhere from 30 days to 12 months, depending on its class and the risk associated with it.
Direct communication with the ANVISA in Brazil is often handled by the local regulatory representative in Brazil, whereas the document submission and approval procedures can be carried out through the official online portal of ANVISA known as PET.
The common reasons for non-compliance of Life Sciences products with ANVISA may include improper documentation, invalid GMP certificate, incomplete labeling and packaging, and incorrect product classification.
ANVISA accepts foreign GMP certification products only from known regulatory authorities such as the FDA and the EU, which are further evaluated by the ANVISA team members. However, this foreign certification is only accepted for low-risk products; for products with high risk, ANVISA requires its own GMP certificate.
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Industries We Serve in the Brazil

Regulatory and compliance expert – Artixio

Pharmaceuticals

Compliance and regulatory consulting – Artixio
Medical device regulatory services – Artixio

MedTech

Compliance and regulatory consulting – Artixio
Cosmetics regulatory consulting – Artixio

Cosmetics

Compliance and regulatory consulting – Artixio
Nutrition regulatory consulting – Artixio

Nutrition

Compliance and regulatory consulting – Artixio
Biologics regulatory consulting – Artixio

Biologics

Compliance and regulatory consulting – Artixio
Veterinary regulatory consulting – Artixio

Veterinary

Compliance and regulatory consulting – Artixio
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Our Global Reach: Serving Life
Sciences Clients Worldwide

India Artixio – Regulatory affairs consulting expert

India

Singapore Artixio – Regulatory affairs consulting expert

Singapore

Mexico Artixio – Regulatory affairs consulting expert

Mexico

Brazil Artixio – Regulatory affairs consulting expert

Brazil

Vietnam Artixio – Regulatory affairs consulting expert

Vietnam

Malaysia Artixio – Regulatory affairs consulting expert

Malaysia

Argentina Artixio – Regulatory affairs consulting expert

Argentina

Colombia Artixio – Regulatory affairs consulting expert

Colombia

Taiwan Artixio – Regulatory affairs consulting expert

Taiwan

China Artixio – Regulatory affairs consulting expert

China

Europe Artixio – Regulatory affairs consulting expert

Europe

Thailand Artixio – Regulatory affairs consulting expert

Thailand

Indonesia Artixio – Regulatory affairs consulting expert

Indonesia

Philippines Artixio – Regulatory affairs consulting expert

Philippines

USA Artixio – Regulatory affairs consulting expert

USA

Japan Artixio – Regulatory affairs consulting expert

Japan

Qatar

South Korea

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