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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.
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 Affairs
Product Registration
Market Access
IND (Investigational New Drug)
NDA (New Drug Application)
Regulatory Operations
Technical Writing
Regulatory Strategy
Market Access
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
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.
2. How to approach the regulatory bodies in Brazil, and what are the modes of communication?
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.
3. What are the common reasons for non-compliance with ANVISA regulations in Brazil?
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.
4. Does ANVISA accept a foreign GMP certificate, or is a Brazilian GMP certificate mandatory?
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.
Industries We Serve in the Brazil
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
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