Clinical Development and Drug Licensing in Brazil & Latin America
We help biopharmaceutical companies run clinical trials in Brazil — sites, PIs, patients and medical affairs — and advise on drug licensing and partnering across Latin America.
We help biopharmaceutical companies run clinical trials in Brazil — sites, PIs, patients and medical affairs — and advise on drug licensing and partnering across Latin America.
Market Opportunity
The ideal destination for your next clinical trial
Largest market in Latin America
With 212 million people, Brazil offers unparalleled patient recruitment potential in a single country.
Competitive trial costs without compromising on quality or regulatory standards. Maximize your R&D budget.
ANVISA provides responses within 90 business days, enabling faster trial initiation than many other markets.
A unique melting pot of Indigenous, European, African, and Asian heritage for diverse trial populations.
Access highly sophisticated, well-equipped clinical research sites with experienced investigators.
Convenient time zone overlap with the U.S. for seamless real-time collaboration.
About Us
SambaTrials combines deep cell therapy development experience with over 15 years navigating Brazil's regulatory and clinical research landscape. We're your strategic partner on the ground — for running trials in Brazil and for licensing deals across Latin America.
Specialized knowledge in NK-cell, CAR-T, and next-generation cell therapy clinical development.
Deep relationships with top-tier clinical research institutions and experienced investigators across Brazil.
Proven track record of successful regulatory submissions and approvals with Brazil's health authority.
From site selection to medical affairs, from asset scouting to alliance management — we cover the full lifecycle.
Two Practices
Hands-on clinical development support for trials in Brazil, and licensing advisory that connects global innovators to Latin American markets — while helping Brazilians gain early access to cutting-edge therapies.
End-to-end medical support for your trial in Brazil — site and PI identification, patient recruitment, pre-study assessments and medical-affairs operations. One accountable partner on the ground.
Optimal sites, experienced Principal Investigators and qualified patients — identified and engaged through our network across Brazil's top research institutions.
Expert navigation of the Brazilian regulatory landscape — direct ANVISA meeting coordination, documentation and submission support.
We source, evaluate and help negotiate drug-licensing opportunities across Latin America — connecting global innovators with established regional licensees, from first contact to signed deal.
Systematic scouting of US and European assets — licensing-ready dossiers, market sizing and competitive intelligence, powered by BioAlma.
Ongoing support between originator and licensee after signing — governance, reporting and neutral bilingual reconciliation that keeps partnerships healthy.
FAQ
ANVISA typically provides regulatory responses within 90 business days. With proper preparation, you can go from submission to first patient enrolled in 6-9 months.
We specialize in cell therapy trials (NK-cell, CAR-T) but support all phases (I-IV) across therapeutic areas including oncology, autoimmune diseases, and rare diseases.
Yes, Brazilian regulation requires a local sponsor or representative. SambaTrials can serve as your in-country partner, handling regulatory submissions, site management, and local operations.
Clinical trial costs in Brazil are typically 30-50% lower than the US and Europe, while maintaining comparable quality standards and GCP compliance.
ANVISA is Brazil's National Health Surveillance Agency (similar to the FDA). They review clinical trial applications and have streamlined their process to respond within 90 business days for most submissions.
Get Started
Let's discuss your trial — or your next licensing deal. One partner for clinical development and market entry across the region.
Access to 800+ research sites across Brazil
ANVISA regulatory response in 90 days
Time zone aligned with US East Coast
Genetically diverse patient population