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A Reference in
Bioequivalence and
Phase I Clinical Trials

Synvia

1,600+ studies already conducted

Synvia was founded in 2005 as CAEP – Advanced Center for Studies and Research. Today, we conduct over 200 pharmaceutical bioequivalence studies annually and have built deep expertise in developing and validating bioanalytical methods.

With a track record of high-impact projects, we are committed to delivering top‐quality services and offering strategic support to our sponsors.

Medicamentos Genéricos e Bioequivalência nos laboratórios da Synvia

Our Bioequivalence Studies

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Harmonized LATAM Studies

We conduct harmonized bioequivalence studies under international guidelines, ensuring our results are consistent and accepted by regulatory agencies across Latin America.

Submission Studies for Europe (EMA)

We have extensive experience conducting studies for submission to the European Medicines Agency (EMA), ensuring full regulatory compliance and adherence to the highest standards.

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15,000 m² of State-of-the-Art Specialized Infrastructure

Fully equipped facilities that meet end-to-end projects, ensuring maximum efficiency and agility.

Clinical Facilities

Dedicated unit for participant recruitment (screening), with the capacity for more than 5,000 screenings per month.

Intensive observation rooms equipped with ambulatory cardiac monitoring and access to emergency care.

Specialized medical team with 24-hour assistance throughout the study period.

Integrated system for data management and electronic data capture during trials.

Safe, temperature-controlled area for medication storage.

162 beds in 4 wards with varied layouts to simultaneously accommodate different types of studies.

Dozens of Ultrafreezers and Freezers for different temperatures equipped with alarm and monitoring systems to ensure the safe storage of biological samples.

Bioanalytical Laboratory

We have a highly qualified technical team, including master’s and Ph.D. experts in method development and validation.

500+ methods

Developed and validated bioanalytical methods.

100,000+ samples

Analytical capacity exceeding 100,000 samples per month.

The Largest Analytical Park

O maior Parque Analítico da América Latina. Nossas instalações modernas incluem equipamentos de ponta, como:

The largest analytical park in Latin America. Our state-of-the-art facilities include cutting-edge equipment, such as:

Multiple support areas dedicated to providing the best experience for our clients and maintaining excellence in all processes.

Multiple support areas dedicated to providing the best experience for our clients and maintaining excellence in all processes.

Project Feasibility

Detailed assessment, including technical discussions and expertise exchange.

Project Management

Real-time tracking to ensure transparency and compliance with deadlines.

Participant Recruitment

Optimized recruitment through multiple channels and artificial intelligence.

Communication and Marketing

Targeted strategies to effectively attract new participants.

COMEX

Efficient importation of supplies and standards.

Technical Documentation

Preparation of precise and detailed analyses and reports.

Quality Assurance

A robust system aligned with the highest regulatory standards, including internal audits and external inspections.

Our solutions

Bioequivalence Studies

Bioanalytical
Services

Pharmaceutical
Equivalence

Phase I Clinical
Trials (PK/PD)

Biostatistics

Analytical
Services

Equipamentos HPLCs nos laboratórios da Synvia

Bioequivalence Studies

Phase I Clinical Trials (PK/PD)

Bioanalytical Services

Biostatistics

Pharmaceutical Equivalence

Analytical Services

Equipamentos HPLCs nos laboratórios da Synvia

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Quote

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