We develop customized methodologies to meet the specific needs of the pharmaceutical industry, whether for research and development or quality control.
We are strategic partners for international companies seeking to conduct pharmaceutical equivalence studies in Brazil, with consolidated expertise in antineoplastics and other high-complexity therapeutic classes.
Our services
Pharmaceutical Equivalence
Synvia is an ANVISA-accredited Pharmaceutical Equivalence Center, registered under No. 4667.
We conduct comprehensive Pharmaceutical Equivalence studies, covering physicochemical and microbiological assays, in full compliance with RDC No. 31/2010.
We perform assays across solid, semi-solid, and liquid dosage forms, including antineoplastic drugs and other high-criticality molecules.
Comparative Dissolution Profile
We conduct Comparative Dissolution Profile (CDP) studies for post-registration purposes, in full compliance with the requirements of RDC No. 73.
The CDP is required by ANVISA in various regulatory contexts, including changes in manufacturing site, raw material supplier, or production process.
It may also be a necessary step in the planning and conduct of bioequivalence studies.
Biowaivers
We cover the full scope of Biowaiver studies in accordance with RDC No. 749/2022.
The service applies to generic, similar, new, and innovative drugs, including post-registration situations.
Covering the majority of dosage forms provided for in current regulations, our team assesses the most appropriate biowaiver strategy for each project.
Assays with Oncological Drugs
ANVISA-authorized laboratory for conducting pharmaceutical equivalence studies and other assays involving oncological drugs.
Analyses are conducted in dedicated areas, with specific biosafety procedures, a highly qualified team, and continuous monitoring.
The Largest Analytical Park in Latin America
Our modern facilities include state-of-the-art equipment, such as:
Validated infrastructure compliant with global regulatory standards
Our facilities meet international quality and safety standards, ensuring the traceability and credibility of every result delivered.
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.
