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Solutions in
Pharmaceutical Equivalence
and Analytical Services

Expertise and precision to ensure
your project's success

EQFAR Center and Analytical Services

In vitro assays for drug registration are conducted in full compliance with ANVISA Resolutions. This includes studies on pharmaceutical equivalence, dissolution profiles, biowaiver, solubility studies, dissolution dossier, as well as the development and validation of analytical methods.

We develop customized methodologies to meet specific needs in the pharmaceutical sector, whether in the context of research and development or quality control.

We operate as allies in global expansion, particularly for international industries needing equivalence studies in Brazil, with a special focus on sectors such as antineoplastic drugs.

Testes com medicamentos em laboratório. Equivalência farmacêutica (EQFAR) e Serviços analíticos.

Explore our solutions

For recurring or seasonal demands, our solutions offer the flexibility and reliability required for the success of your business, ensuring exceptional quality and strict compliance with deadlines.

Pharmaceutical Equivalence

Pharmaceutical equivalence ensures that generic and reference drugs contain the same active ingredient, at the same concentration, in the same dosage form, and with the same route of administration.
Through rigorous quality standards, we ensure that both products share identical qualitative and quantitative composition of active ingredients, while meeting the same purity and potency requirements.

HPLC e LC-MS/MS para análises com medicamentos. na Synvia.

Dissolution Profile

Comparative dissolution profiling is essential for quality control and drug development. By evaluating the release of the active ingredient in media that simulate the physiological conditions of the gastrointestinal tract, this analysis determines the similarity between a test drug and a reference drug.

This comparison ensures that generic or similar medications exhibit equivalent therapeutic performance to the original product. Synvia employs rigorous methods and advanced technologies to conduct these studies, ensuring effective, safe and high-quality products for patients.

Dissolutores e outros equipamentos no laboratório de EQFAR da Synvia, utilizados para perfis de dissolução, bioisenção e muito mais.

Biowaiver

Biowaivers allows the substitution of in vivo bioequivalence clinical trials with in vitro dissolution analyses when certain criteria are met. This method evaluates the dissolution of the drug from the pharmaceutical form.

By applying biowaivers, we accelerate the development and commercialization of generic drugs, reducing costs and time without compromising quality, safety and efficacy. This enhances the pharmaceutical industry's competitiveness and expands the population's access to essential drugs.

Dissolutores e demais equipamentos no laboratório da Synvia

Serviços Analíticos

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Laboratory authorized by ANVISA with high biosafety standards for pharmaceutical equivalence testing of oncology drugs.

Our expertise enables us to transform challenges into precise and reliable results.

At Synvia, we combine over 20 years of experience in the pharmaceutical sector with a highly qualified team to deliver solutions that make a difference.

200+

pharmaceutical industry clients served in Brazil and worldwide

800+

multidisciplinary professionals, including dozens of master’s and Ph.D. holders with high-level technical and scientific expertise

15,000 m2

of proprietary and specialized infrastructure

State-of-art technology

and an unwavering commitment to quality and precision

Mestres e doutores em equivalência farmacêutica e serviços analíticos na Synvia.

The largest analytical park in Latin America.

Modern facilities equipped with cutting-edge technology, including:

O maior parque analítico da América Latina.

Instalações modernas com equipamentos de ponta, como:
maior-parque-analitico

Areas Supporting the Excellence of Laboratory Analysis

Our strategic internal support areas ensure agility and quality across all processes.

Project Viability

Area specialized in the evaluation and optimization of resources, deadlines, and investments to ensure each project achieves its full potential.

Project Management

Area responsible for real-time monitoring, ensuring full visibility and strict compliance with agreed deadlines.

COMEX

Experts in the efficient importation of standards and raw materials essential for analytical processes.

Technical Documentation

A dedicated area for producing detailed analyses and precise reports, ensuring clarity and reliability in the presented results.

Quality Assurance

A comprehensive system aligned with the highest technical and regulatory standards, to guarantee total quality across all stages.

Estudos de Bioequivalência

Serviços de CRO

Bioestatística

Estudos Clínicos
Fase I (PK/PD)

Explore other services offered by Synvia

Bioequivalence Studies

Bioanalytical Services

Phase I
Clinical Trials (PK/PD)

Biostatistics

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