Bioequivalence Mexico

Harmonized Bioequivalence Study

Harmonized bioequivalence studies follow standardized international guidelines, ensuring that they are conducted consistently across different countries and that the results are comparable and accepted by various regulatory agencies.

Our experienced technical team supports the design of regulatory strategies that allow a single study to be used for submissions in different Latin American countries.

ANVISA oversight

ANVISA is internationally recognized for its quality in pharmaceutical regulation. Conducting bioequivalence studies in a center certified by the agency ensures adherence to strict quality standards. As a regulatory member of the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), the agency holds credibility in international regulatory affairs related to drug registration.

Growing pharmaceutical market

A harmonized study allows the medication to be registered in both Mexico and Brazil, the latter having a continuously advancing pharmaceutical market. It presents a promising scenario for international investment.

Why conduct studies with Synvia in Brazil?

Our team of specialists is ready to help you achieve your goals in the Mexican, Brazilian and international pharmaceutical markets. Get in touch:

Mário Giordano, 146 - Jardim América, Paulínia - SP, 13140-614 - Brazil

All the quality of the largest bioequivalence center in Latin America now also available for submissions in Mexico

Synvia conducts studies for drugs to be registered in Mexico at our facilities in Brazil.

All requirements of the Mexican regulatory agency (COFEPRIS) are met with precision, safety, and exceptional quality, enabling the interchangeability of the medication in the country.

Cost-benefit

Conducting bioequivalence studies with Synvia allows pharmaceutical companies to maximize resources without compromising quality.

The best solution for Bioequivalence Studies.

Discover why Synvia is the ideal choice for the international pharmaceutical market.

20 years of experience

Synvia is a national and international reference in bioequivalence studies, having conducted over 1,600 studies.

Highly skilled technical-scientific team

Our team of specialists collaborates closely with sponsors, ensuring transparency and confidence in the results. We offer complete support, from document preparation to post-study follow-up.

Guaranteed regulatory compliance

We conduct studies in full compliance with Mexican regulations and rigorously adhere to global Good Clinical Practice guidelines, ensuring your medication meets all requirements to be considered interchangeable in Mexico.

State-of-the-art technologies

and processes

We utilize advanced technologies and innovative methodologies to ensure the accuracy and reliability of study results. With over 100,000 samples processed monthly in our bioanalytical laboratory and more than 4,000 tests in our portfolio.

Comprehensive solutions for agility in your project

A dedicated participant recruitment team with over 150,000 potential participants in our database, along with internally optimized processes that expedite studies.