Regulatory Affairs Services Provider in Brazil
Welcome to your gateway to the Brazilian market.DDReg serve as a specialised regulatory affairs consulting firm in Brazil, committed to helping pharmaceutical, biotech, cosmetics medical - device and food companies with the complex and evolving regulatory landscape of Brazil.Whether you’re seeking to obtain a first marketing authorisation, manage lifecycle changes, support food - regulatory compliance or engage with the Agência Nacional de Vigilância Sanitária(ANVISA) we are your strategic regulatory services provider in Brazil.
Understanding the ANVISA Regulatory Framework
The Agência Nacional de Vigilância Sanitária(ANVISA) is Brazil’s national regulatory agency responsible for ensuring the safety, efficacy, and quality of pharmaceuticals, biologicals, cosmetics, medical devices, and food products.
ANVISA’s core functions include:
- Evaluation and approval of new drugs and clinical trials
- Oversight of manufacturing, import, and commercialization of regulated products
- GMP certification and facility inspections
- Regulation of labeling, advertising, and pharmacovigilance
- Alignment with international best practices through ICH, PAHO, and WHO collaborations
As an experienced Regulatory Affairs Services Provider in Brazil, DDReg collaborates closely with local representatives and ANVISA to deliver compliant, complete, and timely regulatory submissions. We also provide Regulatory intelligence to keep you updated with ANVISA regulations.
Our Regulatory Affairs Services Expertise in Brazil
- End-to-end product registration and market authorization in Brazil
- In-country representation and authorized local agent services
- Strategic regulatory affairs consulting and submission planning
- Dossier gap analysis and compliance alignment with ANVISA guidelines
- Query management and communication support with ANVISA until approval
- Pharmaceutical product lifecycle compliance and maintenance
- Expert regulatory consultation and guidance
- Regulatory support for labeling, variations, and renewals
- Monitoring of ANVISA updates
Why Partner with DDReg for Regulatory Affairs Services in Brazil?
- ANVISA-focused expertise: Deep understanding of local regulations and submission pathways.
- Global experience, local insight: Seamless integration of global standards with Brazil-specific requirements.
- Accelerated approvals: Proven regulatory strategies that minimize delays and rejections.
- Comprehensive lifecycle support: From submission to post-approval maintenance, DDReg ensures sustained compliance.
Start Your Regulatory Journey with DDReg
Whether you’re introducing a new product, managing renewals, or navigating ANVISA’s updated guidelines, DDReg provides end - to - end Regulatory Affairs Consulting Services in Brazil tailored to your business goals.
