Artixio

Life Sciences Compliance Services In Brazil

Simplifying your regulatory journey in Brazil, from product conceptualization to market entry and ongoing compliance maintenance.
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

MAPA

Ensure Seamless Regulatory Compliance In Brazil with Artixio:

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.

Why Trust Artixio with Your Regulatory Journey In Brazil?

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

Our Services

Regulatory Affairs
Product Registration
Market Access
IND (Investigational New Drug)
NDA (New Drug Application)
Regulatory Operations
Technical Writing
Regulatory Strategy
Market Access

Industries We Serve in the Brazil

Pharmaceuticals

MedTech

Cosmetics

Nutrition

Biologics

Veterinary

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.

Our Global Reach: Serving Life
Sciences Clients Worldwide

India

Singapore

Mexico

Brazil

Vietnam

Malaysia

Argentina

Colombia

Taiwan

China

Europe

Thailand

Indonesia

Philippines

USA

Japan

Qatar

South Korea

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