Regulatory Excellence
Regulatory rigor with business vision
Regulatory consulting plus Holder and representation solutions for market access in Brazil, the United States and Europe.
Two lines of business
Regulatory consulting and Registration Holder
Regulatory Consulting
Product registration with ANVISA, INMETRO certifications, CE Mark/FDA and Quality Management Systems — from the technical dossier to post-registration maintenance.
International Holder & Representation
For foreign companies in Brazil and Brazilian companies entering the U.S. and Europe: ANVISA, FDA and CE marking support.
Our clients
Industries that trust CGA
Regulatory AI assistant
Get regulatory answers from CGA's AI
A virtual expert trained on regulatory affairs and product registration: ANVISA, Registration Holder, GMP, labeling and post-market. Every answer includes its information sources.
- Specialized answers, always with cited sources
- Knowledge base maintained by the CGA team
- Exclusive for registered clients — history and monthly quota per user
CGA Regulatory Assistant
Sourced technical guidance on ANVISA, GMP, ISO 13485, CE Marking, FDA and Brazilian Registration Holder services.
To use the Assistant, we collect your contact details and the full conversation. Our technical and administrative team may review and audit interactions. Please read the documents before agreeing.
New line of business
International Holder & Representation
Solutions for foreign companies entering Brazil and Brazilian companies accessing the U.S. and Europe, with ANVISA, FDA and CE marking support.
- Registration ownership under a company authorized in Brazil
- Technical responsibility and response to ANVISA requirements
- Labeling, instructions for use and national regulatory adaptation
- Post-market surveillance, amendments and registration renewals
Events and training
Regulatory training for your team
Webinars and training on standards, good practices and national and international regulatory updates.
Testimonials
What companies already working with CGA say
“We are very satisfied with CGA Consulting's service; the results we achieve are always positive and lasting. Beyond technical capability, flexibility and reliability, there is a commitment to bringing us options that best fit our reality.”
Liliane Jaber
Kinner Silicone Rubber
“CGA Consulting acts as a strategic partner in the regulatory area, demonstrating high technical capability and professionalism, always proposing solutions that adapt to our reality amid a complex and constantly evolving regulatory environment.”
Willian Teodoro Higino
Ventura Biomédica
“Working with CGA Consulting brought us, beyond partnership, confidence in the technical support offered, with a very competent and up-to-date team.”
Alexsandra Oliveira
Bionnovation