Bioequivalence Studies for Registration in Mexico (COFEPRIS)
A Synvia
Leadership in Bioequivalence
and Clinical Research in Latin America
With over 20 years of experience, Synvia combines reference infrastructure, scientific rigor, and international regulatory expertise to support the pharmaceutical industry in the registration of medicines in Mexico and throughout LATAM.
Our schedule, your differential
Our numbers
20,000 m² of dedicated infrastructure
Operational excellence at all stages of the study.
Modular wards and intensive observation rooms
162 beds distributed across four independent wards, allowing the simultaneous conduction of different clinical studies with total operational isolation and control of variables, and rooms equipped with continuous cardiac monitoring.
The largest analytical park in Latin America for mass spectrometry
We have a bioanalytical capacity of over 100,000 samples per month, operating with state-of-the-art technologies.
There are over 30 LC-MS/MS systems in continuous operation, ensuring high sensitivity and analytical precision.
Our structure, fully integrated with the clinical units, guarantees operational efficiency, complete traceability, and results with an international standard.
High-scale recruitment
We have a team of 50 professionals dedicated exclusively to recruitment and proprietary tools that accelerate each stage of the process.
With intelligent chatbots, multichannel communication, and segmented workflows, we ensure quick, accurate screenings compatible with studies of different complexities.
+5.000
screenings/month
+150.000
people in databases
Total compliance with COFEPRIS criteria
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.
Operational excellence at all stages of the study.
Feasibility of projects
Before conducting each study, Synvia performs a comprehensive scientific assessment, considering all technical, clinical, and bioanalytical aspects that ensure the methodological consistency and regulatory success of the project.
Project management
We monitor each study in an integrated manner - from the initial planning to regulatory submission - ensuring visibility, control, and compliance with deadlines at all stages.
Foreign trade
Why choose Synvia
Experience, compliance, and scientific accuracy
Synvia has a history of success in studies submitted and approved by different regulatory authorities.
Our operational model follows global quality standards, ensuring complete traceability and trilingual documentation.
