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ACCELERATING THE FUTURE OF HUMAN IN VITRO DIAGNOSTICS

Imagine o impacto de um diagnóstico veterinário preciso e oportuno. ???????? Na Enzytec, nós tornamos essa visão uma realidade, desenvolvendo ensaios e kits inovadores para diagnósticos veterinários. Trabalhando em parceria com instituições de renome, como a Escola de Veterinária da UFMG, estamos trazendo para o mercado soluções inovadoras em diversas plataformas de diagnóstico. Seja como […]

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ACCELERATING THE FUTURE OF HUMAN IN VITRO DIAGNOSTICS

Do you believe that time is the most valuable resource in the scientific development journey? At Enzytec, we think so too! ???????? We work diligently as your R&D partner, or directly as your R&D, providing swift and effective solutions for in vitro product development. With our vast experience in human diagnostics, we can speed up

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Enzytec: Integrated and Customized Solutions in Regulatory Affairs

The complexity of the regulatory field is an undeniable reality. However, Enzytec, with its diverse range of services, plays a crucial role in simplifying this process, allowing companies to focus on what they do best. We offer services ranging from product registration with ANVISA and MAPA, which cover a wide range of products for human

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The Challenges of Product Registration with ANVISA and MAPA: Overcome with Enzytec

Product registration with ANVISA and MAPA is a complex and challenging process. It encompasses a broad range of aspects, from demonstrating efficacy and safety to proving compliance with stringent manufacturing and quality standards. Here at Enzytec, we specialize in navigating these turbulent waters. With our deep understanding of ANVISA and MAPA regulations and processes, we

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Unraveling Regulatory Complexity: Raw Material vs Finished Product

Within the realm of sanitary regulation, outlined by ANVISA, the differentiation between ‘raw material’ and ‘finished product’ sparks a profound and intricate discussion. This distinction, though seemingly just semantic, carries a host of regulatory, operational, and commercial implications, shaping the very structure of the global production chain. ?? Typically, we designate as ‘raw materials’ the

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Enzytec launches solution that eliminates the use of Level 2 biosecurity chambers in rapid tests for COVID

ENZYTEC NEWS Enzytec launches solution that eliminates the use of Level 2 biosecurity chambers in rapid tests for COVID For the development and evaluation of tests for COVID-19, one of the major barriers that manufacturers of IVD kits encounter, due to current legislation, is the need to use Biosafety Level 2 chambers and procedures in

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Enzytec supports Medmax in Standardizing the Manufacturing of Rapid Immunochromatographic Tests

ENZYTEC NEWS Enzytec supports Medmax in Standardizing the Manufacturing of Rapid Immunochromatographic Tests Continuing the partnership with MEDMAX, Enzytec carried out in June 2022 the production of immunochromatographic rapid tests at the company. For the production of the tests, the specifications of humidity (

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RDC 687/22

ENZYTEC NEWS RDC 687/22 The new RDC 687 came into force in May 2022, which provides for the criteria for granting or renewing the Certification of Good Manufacturing Practices for Medical Devices, complementing the general provisions of administrative procedures for granting the Certification of Good Manufacturing Practices. According to the Federal Official Gazette, RDC 687/22,

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