Regulatory Excellence
International Holder and regulatory representation
CGA provides Holder and regulatory representation solutions for foreign companies entering Brazil and Brazilian companies seeking access to the United States and European Union. We support compliance with ANVISA, FDA and applicable CE marking requirements.
Market access
For foreign companies entering Brazil
CGA can hold the ANVISA registration, supporting product regularization, importation and commercialization in Brazil.
For Brazilian companies entering the U.S. market
We support regulatory strategy and execution, including the applicable representation structure and FDA-related steps.
For Brazilian companies entering Europe
We support CE marking readiness and the applicable regulatory representation structure in the European Union.
Regulatory AI assistant
Sourced technical guidance on ANVISA, GMP, ISO 13485, CE Marking, FDA and Brazilian Registration Holder services.
Sourced technical guidance on ANVISA, GMP, ISO 13485, CE Marking, FDA and Brazilian Registration Holder services.
Hello! I am CGA Consulting's AI Assistant. I can clarify technical questions about standards, GMP and ANVISA registrations.
Why choose CGA
We assess the product, destination market and available documentation to define a consistent pathway.
We support ANVISA, FDA and CE marking projects while respecting each jurisdiction.
We support changes, renewals, authority requests and post-market obligations.
A well-defined structure increases control over market entry and ongoing access.
How it works
A structured regulatory journey tailored to your product and destination market.
Analysis of product, intended use, classification, documentation and target markets.
Definition of the applicable ANVISA, FDA or European Union pathway.
Definition and formalization of the appropriate Holder or regulatory representation model.
Preparation, review and adaptation of the required technical documentation.
Process follow-up and ongoing support for changes, renewals and post-market obligations.
Our clients
