Unidade clínica da Synvia com leitos dedicados à condução de estudos de bioequivalência e estudos clínicos Fase I (PK/PD)

Bioequivalence

Bioequivalence and Phase I Clinical Studies (PK/PD)

Reference in bioequivalence standards ANVISA, EMA, and FDA

Since 2005, Synvia has been conducting clinical and bioanalytical studies, including bioequivalence studies in healthy participants and patients, with complete infrastructure, specialized staff, and compliance with the highest international regulatory standards.

20+ years

20+ years

of excellence

2k+

2k+

conducted studies

conducted studies

Specialization

Clinical bioequivalence studies focusing on generics and similar products.

High capacity

More than 200 studies conducted per year, with a consolidated structure.

Strategic partnership

Technical and scientific support for sponsors at all stages of the study.

Specialization

Clinical bioequivalence studies focusing on generics and similar products.

High capacity

More than 200 studies conducted per year, with a consolidated structure.

Strategic partnership

Technical and scientific support for sponsors at all stages of the study.

Regulatory harmonization for global bioequivalence studies

Harmonized protocols according to ANVISA, EMA, and FDA, with standardized methods and global documentation to reduce timelines and simplify the international registration of medicines.

0%

Certified quality

We operate with full adherence to international standards of quality, safety, and scientific ethics, following FDA and EMA guidelines.

20,000 m² of complete infrastructure, ready for bioequivalence studies

Complete installations that meet end-to-end projects, ensuring maximum efficiency and agility.

Unidade clínica da Synvia com leitos dedicados à condução de estudos clínicos de alta complexidade

Screening unit (5,000+ participants/month)

Intensive observation rooms

24-hour medical team

Integrated electronic data system (eCRF)

Secure storage of medications

162 beds in 4 adaptable layouts per study

Dozens of ultrafreezers and monitored freezers

Integrated bioanalytical laboratory with the clinical center

Our technical team consists of dozens of MSc and PhD specialists in the development and validation of bioanalytical methods. The integration between the laboratory and the clinical center ensures operational efficiency, traceability, and global compliance.

100,000+

samples/month

500+

bioanalytical methods

Laboratório bioanalítico da Synvia integrado ao centro clínico para validação de métodos e estudos bioanalíticos
Laboratório da Synvia com equipamentos de espectrometria de massas LC-MS/MS no maior parque analítico da América Latina
Laboratório da Synvia com equipamentos de espectrometria de massas LC-MS/MS no maior parque analítico da América Latina

The largest analytical park in Latin America for mass spectrometry

30+ LC-MS/MS

30+ LC-MS/MS

25+ LC-DAD

25+ LC-DAD

GC-FID

GC-FID

GC-MS/MS

GC-MS/MS

ICP-MS

ICP-MS

ICP-OES

ICP-OES

LC-FL

LC-FL

UV-Vis

UV-Vis

Dissolution and Apparatus I, II and III

Dissolution and Apparatus I, II and III

Excellence at every stage of study

From feasibility to final delivery, our technical and operational areas work together to ensure quality, agility, and full regulatory compliance.

Feasibility of projects

Feasibility of projects

History of the Center

History of the Center

Clinical stage

Clinical stage

Bioanalytical stage

Bioanalytical stage

Equipe técnica da Synvia apresentando planejamento e gestão integrada de estudos clínicos e bioanalíticos
Equipe técnica da Synvia apresentando planejamento e gestão integrada de estudos clínicos e bioanalíticos

Pharma Solutions

Integrated solutions for the pharmaceutical industry

From clinical research to laboratory analyses and regulatory studies, our Pharma solutions connect all the necessary steps for the development, validation, and registration of medications.

Tailored studies for high-complexity projects

We conduct customized projects with technical expertise and regulatory support.

Contact

Talk to our experts

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

Contact

Talk to our experts

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