Bioequivalence - Synvia
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Reference in
Bioequivalence and
Phase I Clinical Trials

Synvia Labs

1,600+ studies already conducted

Founded in 2005 as CAEP – Advanced Center for Studies and Research, Synvia Labs conducts more than 200 pharmaceutical bioequivalence studies every year, consolidating deep experience in the development and validation of bioanalytical methods.

With a trajectory marked by high-impact projects, we are committed to delivering high-quality services and providing strategic support to our sponsors.

medicamentos genéricos

Synvia Labs Studies

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Harmonized LATAM Studies

We conduct harmonized bioequivalence studies according to standardized international guidelines, ensuring consistency and acceptance of results by various regulatory agencies in different Latin American countries.

Submission Studies for Europe (EMA)

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

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15,000 m² of Complete and 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

nossas-solucoes

Bioequivalence Studies

Phase I Clinical Trials (PK/PD)

Bioanalytical Services

Biostatistics

Pharmaceutical Equivalence

Analytical Services

nossas-solucoes

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