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CRO full-service

Your full-service CRO in Brazil: from protocol to registration

Complete and modular solutions (Phases I to IV)

For over 20 years, we have conducted clinical studies for 200+ pharmaceutical companies in one of Latin America's most competitive regulatory environments. We combine integrated operations, proprietary technology, and regulatory expertise to reduce timelines and protect data quality.

Full-service portfolio

Modular and personalized approach

Collaborators

+870

Collaborators

+870

Global sponsors

+175k

Global sponsors

+175k

Clinical studies conducted

+0k

Clinical studies conducted

+0k

Research participants

+0k

Research participants

+0k

What we deliver at every stage of your study

Hire the full package or just the modules your operation needs with a single point of contact and GCP/ICH standards from start to finish.

Scientific Consulting & Feasibility

Feasibility assessment — technical, regulatory, and operational — with risk mapping before committing budget.

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Scientific Consulting & Feasibility

Feasibility assessment — technical, regulatory, and operational — with risk mapping before committing budget.

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Project Management & Clinical Monitoring

Center, CRA, and vendor coordination with on-site and remote monitoring per GCP/ICH and transparent oversight for the sponsor.

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Project Management & Clinical Monitoring

Center, CRA, and vendor coordination with on-site and remote monitoring per GCP/ICH and transparent oversight for the sponsor.

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Regulatory Affairs & Ethics Dossier

ANVISA and CEP/CONEP submissions, CTD dossiers, DDCM/DEEC, Gap Analysis, and Due Diligence — with a proven approval track record.

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Regulatory Affairs & Ethics Dossier

ANVISA and CEP/CONEP submissions, CTD dossiers, DDCM/DEEC, Gap Analysis, and Due Diligence — with a proven approval track record.

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eCRF & Data Management

Data capture, validation, and lock via proprietary eCRF with automated edit checks, full audit trail, and 21 CFR Part 11 compliance.

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eCRF & Data Management

Data capture, validation, and lock via proprietary eCRF with automated edit checks, full audit trail, and 21 CFR Part 11 compliance.

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Medical Writing & Scientific Documentation

Protocols, CSRs, IBs, ICFs, and manuscripts with ICH standardization, written and delivered in Portuguese, English, and Spanish.

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Medical Writing & Scientific Documentation

Protocols, CSRs, IBs, ICFs, and manuscripts with ICH standardization, written and delivered in Portuguese, English, and Spanish.

Learn more

Biostatistics

SAP development, sample size calculation, randomization, descriptive and inferential analyses, and TLF preparation — with integrated support for clinical reports and publications.

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Biostatistics

SAP development, sample size calculation, randomization, descriptive and inferential analyses, and TLF preparation — with integrated support for clinical reports and publications.

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Study Start-up

Site selection, qualification, and activation, contracts, and initial submissions — focused on getting the first patient in on time.

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Study Start-up

Site selection, qualification, and activation, contracts, and initial submissions — focused on getting the first patient in on time.

Learn more

Pharmacovigilance & Medical Affairs

Safety monitoring, SAE/SUSAR processing, DSMB support, and medical affairs — with workflows aligned to ANVISA, EMA, and FDA.

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Pharmacovigilance & Medical Affairs

Safety monitoring, SAE/SUSAR processing, DSMB support, and medical affairs — with workflows aligned to ANVISA, EMA, and FDA.

Learn more

Scientific Consulting & Feasibility

Feasibility assessment — technical, regulatory, and operational — with risk mapping before committing budget.

Learn more

Project Management & Clinical Monitoring

Center, CRA, and vendor coordination with on-site and remote monitoring per GCP/ICH and transparent oversight for the sponsor.

Learn more

Regulatory Affairs & Ethics Dossier

ANVISA and CEP/CONEP submissions, CTD dossiers, DDCM/DEEC, Gap Analysis, and Due Diligence — with a proven approval track record.

Learn more

eCRF & Data Management

Data capture, validation, and lock via proprietary eCRF with automated edit checks, full audit trail, and 21 CFR Part 11 compliance.

Learn more

Medical Writing & Scientific Documentation

Protocols, CSRs, IBs, ICFs, and manuscripts with ICH standardization, written and delivered in Portuguese, English, and Spanish.

Learn more

Biostatistics

SAP development, sample size calculation, randomization, descriptive and inferential analyses, and TLF preparation — with integrated support for clinical reports and publications.

Learn more

Study Start-up

Site selection, qualification, and activation, contracts, and initial submissions — focused on getting the first patient in on time.

Learn more

Pharmacovigilance & Medical Affairs

Safety monitoring, SAE/SUSAR processing, DSMB support, and medical affairs — with workflows aligned to ANVISA, EMA, and FDA.

Learn more

Why Brazil is one of the most competitive destinations for clinical studies

Regulatory speed

ANVISA approvals among the fastest in the region — average shorter than many European markets.

Regulatory speed

ANVISA approvals among the fastest in the region — average shorter than many European markets.

Competitive cost

Cost per patient significantly lower than the US and Europe, without compromising quality.

Competitive cost

Cost per patient significantly lower than the US and Europe, without compromising quality.

Audited sites

Network of sites experienced in FDA and EMA audits.

Audited sites

Network of sites experienced in FDA and EMA audits.

Robust recruitment

210 million inhabitants and high ethnic diversity — representative population for global studies.

Robust recruitment

210 million inhabitants and high ethnic diversity — representative population for global studies.

Mature regulatory environment

ICH-aligned regulatory framework with consistent growth in the local pharmaceutical pipeline.

Mature regulatory environment

ICH-aligned regulatory framework with consistent growth in the local pharmaceutical pipeline.

Harmonized Studies

A single protocol, multiple submissions

Studies designed to simultaneously meet the regulatory requirements of multiple Latin American countries, with aligned protocols, trilingual documentation (Portuguese, English, and Spanish), integrated logistics management, and international compliance.

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Logistics management for clinical studies with materials control, importation, and regulatory compliance by Synvia

Integrated logistics and regulatory management

Complete coordination of importation, storage, and transportation of study materials — including ANVISA and Federal Revenue authorizations, monitored security, cost analysis, and regulatory compliance.

SWIFT importation and complete control of materials

Brazilian customs and regulatory authorizations

Storage and monitored security

Cost management and negotiations

Why choose Synvia

What distinguishes us from other CROs in Latin America

More than 2,000 studies conducted, with a proven track record of ANVISA, EMA, and FDA approvals. We operate with trilingual documentation (PT/EN/ES), total traceability, and our own digital ecosystem that provides the sponsor with real-time visibility — from the inclusion of the first patient to the database lock.

More than 2,000 studies conducted, with a proven track record of ANVISA, EMA, and FDA approvals.

We operate with trilingual documentation (PT/EN/ES), total traceability, and a proprietary digital ecosystem that gives the sponsor real-time visibility — from the inclusion of the first patient to the database lock.