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Bioequivalence

Bioequivalence

Bioequivalence

Bioequivalence

Bioequivalence and Phase I Clinical Studies (PK/PD)

Reference in bioequivalence standards ANVISA, EMA, and FDA

The largest analytical park in Latin America for mass spectrometry

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

+2 thousand

+2 thousand

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.

Screening unit (+5,000 participants/month)

Screening unit (+5,000 participants/month)

Screening unit (+5,000 participants/month)

Screening unit (+5,000 participants/month)

Intensive care rooms

Intensive care rooms

Intensive care rooms

Intensive care rooms

24-hour medical team

24-hour medical team

24-hour medical team

24-hour medical team

Integrated electronic data system (eCRF)

Integrated electronic data system (eCRF)

Integrated electronic data system (eCRF)

Integrated electronic data system (eCRF)

Secure storage of medications

Secure storage of medications

Secure storage of medications

Secure storage of medications

162 beds in 4 adaptable layouts per study

162 beds in 4 adaptable layouts per study

162 beds in 4 adaptable layouts per study

162 beds in 4 adaptable layouts per study

Dozens of ultrafreezers and monitored freezers

Dozens of ultrafreezers and monitored freezers

Dozens of ultrafreezers and monitored freezers

Dozens of ultrafreezers and monitored freezers

Integrated bioanalytical laboratory with the clinical center

Our technical team consists of dozens of masters and doctors specialized 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 thousand

samples/month

+500

bioanalytical methods

The largest analytical park in Latin America for mass spectrometry

Our modern facilities include state-of-the-art equipment, such as:

+30 LC-MS/MS

+30 LC-MS/MS

+30 LC-MS/MS

+30 LC-MS/MS

+25 LC-DAD

+25 LC-DAD

+25 LC-DAD

+25 LC-DAD

GC-FID

GC-FID

GC-FID

GC-FID

Antidiabetics

Antidiabetics

Antidiabetics

Antidiabetics

GC-MS/MS

GC-MS/MS

GC-MS/MS

GC-MS/MS

ICP-OES

ICP-OES

ICP-OES

ICP-OES

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

Feasibility of projects

Feasibility of projects

History of the Center

History of the Center

History of the Center

History of the Center

Clinical stage

Clinical stage

Clinical stage

Clinical stage

Bioanalytical stage

Bioanalytical stage

Bioanalytical stage

Bioanalytical stage

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.