Regulatory Affairs Services in Brazil – Product Compliance Across All Sectors

We help you stay on track with the right documentation, timelines, and strategies to meet ANVISA and other authority requirements, across product categories.

Services We Offer

Brazil-Specific Regulatory Support That Works

Bringing a life sciences product to market in Brazil isn’t just about ticking boxes—it’s about understanding how ANVISA works and what each product type demands.

Whether it’s pharmaceuticals requiring clinical data, medical devices demanding INMETRO certification, or cosmetics undergoing ingredient scrutiny, each product must align with ANVISA’s evolving framework.

At Artixio, we help you stay one step ahead. Our team translates global product dossiers to Brazilian regulatory formats, coordinates with legal agents or MA holders, and handles every aspect—from application to post-market. With a clear view of product classification, submission strategies, and local timelines, we help reduce uncertainty and support compliance from the ground up.

Regulatory Authorities in Brazil

Authority	Area of Oversight	Role
ANVISA	All life sciences sectors	Reviews, authorizes, and monitors products including drugs, medical devices, cosmetics, nutritionals, and biologics.
MAPA	Veterinary & Agricultural Products	Regulates animal health products, veterinary medicines, and food of animal origin.
INMETRO	Medical Devices & Equipment	Certification body for regulated device classes requiring quality and safety labels.
CONCEA	Biologics & Research Use	Regulates use of animals in scientific research and supports ethical standards in preclinical trials.

Regulatory Affairs Lifecycle in Brazil

Why Artixio for Brazil Regulatory Services?

FAQs

Q1. What is the role of ANVISA in regulatory approvals?

ANVISA is Brazil’s primary authority for regulating pharmaceuticals, medical devices, cosmetics, food supplements, and biologics. It oversees the safety, efficacy, labeling, and licensing of products before they enter the market.