Pharma

Toxicology

Diagnostics

Software

About us

Blog

Contact

Clinical research with FDA standards for the USA

Synvia

Your gateway to the leading clinical infrastructure in Latin America

Synvia supports pharmaceutical companies in the US with clinical research in compliance with the FDA, bioequivalence, analytical services, and integrated digital solutions.

20+

20+

years of excellence

years of excellence

2,000+

2,000+

studies conducted

studies conducted

Synvia specialist conducting analysis for bioequivalence studies and clinical research in Latin America

A strategic partner for the US pharmaceutical industry

Synvia combines the advantages of the Brazilian market with a global standard execution, providing a single, reliable point for faster, more efficient, and compliant clinical development.

FDA-Ready Studies

Designed and conducted in accordance with FDA guidelines, facilitating submissions in the United States.

FDA-Ready Studies

Designed and conducted in accordance with FDA guidelines, facilitating submissions in the United States.

Cost-Effective Operations

High operational performance with competitive costs, leveraging Brazil's advanced infrastructure and skilled workforce.

Cost-Effective Operations

High operational performance with competitive costs, leveraging Brazil's advanced infrastructure and skilled workforce.

Genetic Diversity

Access to one of the most genetically diverse populations in the world, strengthening the robustness of clinical data.

Genetic Diversity

Access to one of the most genetically diverse populations in the world, strengthening the robustness of clinical data.

Tri-Lingual Documentation

Complete study documentation in English, Portuguese, and Spanish, enabling seamless communication with U.S. sponsors.

Tri-Lingual Documentation

Complete study documentation in English, Portuguese, and Spanish, enabling seamless communication with U.S. sponsors.

Global Regulatory Expertise

Track record of successful submissions to FDA, EMA, and ANVISA, with dedicated regulatory affairs professionals.

Global Regulatory Expertise

Track record of successful submissions to FDA, EMA, and ANVISA, with dedicated regulatory affairs professionals.

Integrated digital platform

The Synvia TrialCore connects data, processes, and teams in real-time, providing full visibility of studies for clients in the USA.

Integrated digital platform

The Synvia TrialCore connects data, processes, and teams in real-time, providing full visibility of studies for clients in the USA.

FDA-Ready Studies

Designed and conducted in accordance with FDA guidelines, facilitating submissions in the United States.

Cost-Effective Operations

High operational performance with competitive costs, leveraging Brazil's advanced infrastructure and skilled workforce.

Genetic Diversity

Access to one of the most genetically diverse populations in the world, strengthening the robustness of clinical data.

Tri-Lingual Documentation

Complete study documentation in English, Portuguese, and Spanish, enabling seamless communication with U.S. sponsors.

Global Regulatory Expertise

Track record of successful submissions to FDA, EMA, and ANVISA, with dedicated regulatory affairs professionals.

Integrated digital platform

The Synvia TrialCore connects data, processes, and teams in real-time, providing full visibility of studies for clients in the USA.

Comprehensive solutions for all stages of drug development

Clinical Research

Clinical trial management Phase I–IV

Clinical trial management Phase I–IV

Bioequivalence and PK/PD studies for FDA submissions

Bioequivalence and PK/PD studies for FDA submissions

Multicentric capability throughout Brazil

Multicentric capability throughout Brazil

More than 5,000 screenings per month

More than 5,000 screenings per month

Learn more

Learn more

Learn more

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

CRO Full Service

Study planning, feasibility, and regulatory strategy

Study planning, feasibility, and regulatory strategy

Data management and biostatistics

Data management and biostatistics

Medical writing and documentation in CTD format

Medical writing and documentation in CTD format

Pharmacovigilance

Pharmacovigilance

Learn more

Learn more

Learn more

Central Laboratory &
Analytical Development

Bioanalytical laboratory with over 100,000 analyses/month

Bioanalytical laboratory with over 100,000 analyses/month

+500 validated methods for different formulations

+500 validated methods for different formulations

Sample storage and logistics management

Sample storage and logistics management

Learn more

Learn more

Learn more

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

Digital Solutions

Synvia TrialCore: the digital core of clinical research

Synvia TrialCore: the digital core of clinical research

eCRF: electronic case report forms for data registration

eCRF: electronic case report forms for data registration

Dashboards and real-time data access for sponsors

Dashboards and real-time data access for sponsors

Greater collaboration and operational efficiency among teams

Greater collaboration and operational efficiency among teams

Learn more

Learn more

Learn more

Our numbers

Trusted by over 200 pharmaceutical companies in Brazil and around the world

Years of experience

+0

Employees

+0

Clinical studies conducted

+0k

Clinical studies conducted

+0k

Specialized infrastructure in m²

+0k

Specialized infrastructure in m²

+0k

Employees

+770

LC-MS/MS in operation

+0

Partner clinical laboratories

+0k

Clinical studies conducted

+0k

Specialized infrastructure in m²

+0k

Cities served daily

+0k

Meeting the highest international standards

Meeting the highest international standards

Our Quality Assurance department, with over 40 specialists, conducts regular audits and inspections to ensure continuous compliance in all processes.

Our Quality Assurance department, with over 40 specialists, conducts regular audits and inspections to ensure continuous compliance in all processes.

ICH-GCP (E6 R2/R3)

Global standard of ethics and quality in clinical studies

ICH-GCP (E6 R2/R3)

ICH E8

Guidelines and Quality by Design applied to clinical development

ICH E8

Helsinki Declaration

Ethical principles for research involving human beings

Helsinki Declaration

21 CFR Part 11

FDA regulation for electronic records and digital signatures

21 CFR Part 11

HIPAA

Protection and confidentiality of health data in the USA

HIPAA

ICH E9 & E10

Statistical principles and guidelines for control groups

ICH E9 & E10

ICH E2F

Development Safety Update Report (DSUR)

ICH E2F

ALCOA+ Principles

Data integrity guidelines

ALCOA+ Principles

Document of the Americas

Good Clinical Practice guide for Latin America

Document of the Americas

Talk to our specialists

Talk to our specialists

Talk to our specialists

Map of Brazil
Map of Brazil

Law 14.784/2024 • Decree No. 12.651/2024 (Oct/2025)

Brazil is the fastest country in Latin America to authorize clinical studies.

With the new ethical legislation, the deadlines have been drastically shortened.

Before

90 days

(IRB + CONEP)

Before

90 days

(IRB + CONEP)

Now

30 days

(IRB/Ethics Committee)

Now

30 days

(IRB/Ethics Committee)

Your path to developing clinical studies in Latin America

Your path to developing clinical studies in Latin America

A clear, efficient flow aligned with global regulatory standards and those of the FDA.

01

Initial consultation

02

Feasibility & proposal

03

Execution of the study

04

Regulatory support

01

Initial consultation

02

Feasibility & proposal

03

Execution of the study

04

Regulatory support

Contact

Talk to our experts

Discover how Synvia can support your studies, analyses, and projects.

Talk to an expert

Contact

Talk to our experts

Discover how Synvia can support your studies, analyses, and projects.

Talk to an expert

Contact

Talk to our experts

Discover how Synvia can support your studies, analyses, and projects.

Talk to an expert