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Clinical Development & Licensing Advisory
Clinical Development & Licensing Advisory

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.

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Market Opportunity

Why Brazil for Clinical Trials?

The ideal destination for your next clinical trial

Massive Scale

Largest market in Latin America

With 212 million people, Brazil offers unparalleled patient recruitment potential in a single country.

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Population

Cost Effective

Competitive trial costs without compromising on quality or regulatory standards. Maximize your R&D budget.

Fast Regulatory

ANVISA provides responses within 90 business days, enabling faster trial initiation than many other markets.

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Genetic Diversity

A unique melting pot of Indigenous, European, African, and Asian heritage for diverse trial populations.

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World-Class Sites

Access highly sophisticated, well-equipped clinical research sites with experienced investigators.

Time Zone Aligned

Convenient time zone overlap with the U.S. for seamless real-time collaboration.

About Us

Decades of experience in Brazil and expertise in Gene-Cell therapies

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.

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Cell Therapy Focus

Specialized knowledge in NK-cell, CAR-T, and next-generation cell therapy clinical development.

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Brazilian Research Sites

Deep relationships with top-tier clinical research institutions and experienced investigators across Brazil.

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ANVISA Navigation

Proven track record of successful regulatory submissions and approvals with Brazil's health authority.

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End-to-End Support

From site selection to medical affairs, from asset scouting to alliance management — we cover the full lifecycle.

Two Practices

Clinical Development & Licensing Advisory

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.

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Clinical Development

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.

Sites & PatientsMedical AffairsRegulatory
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Site, PI & Patient Finding

Optimal sites, experienced Principal Investigators and qualified patients — identified and engaged through our network across Brazil's top research institutions.

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Regulatory & ANVISA Support

Expert navigation of the Brazilian regulatory landscape — direct ANVISA meeting coordination, documentation and submission support.

Licensing Advisory

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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.

Asset Sourcing
Deal Structuring
Market Entry
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Scouting & Intelligence

Systematic scouting of US and European assets — licensing-ready dossiers, market sizing and competitive intelligence, powered by BioAlma.

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Alliance Management

Ongoing support between originator and licensee after signing — governance, reporting and neutral bilingual reconciliation that keeps partnerships healthy.

FAQ

Clinical Trials in Brazil — 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

Ready to expand into Brazil & Latin America?

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

Report · Q2 2026 Brazil LandscapeTherapeutic AreasInsights