ANVISA revisa regra de enquadramento sanitário para PCR ultrassensível

Ultra-sensitive CRP is used to monitor and screen the risk of cardiovascular events, enabling prognosis and preventive monitoring of inflammation and infections in the blood vessels walls, before the manifestation of clinical symptoms, already identifying inflammatory changes in apparently healthy patients. It is a positive acute phase protein, a marker of systemic inflammation, which increases in response to various types …

Presença confirmada no PoCT Day SBPC/ML 2025

Um time-to-market efetivo depende do atendimento preciso às exigências regulatórias de validação de seu produto. Conte com nossa assistência passo-a-passo para a introdução bem-sucedida de seus testes no mercado de saúde brasileiro. Nos encontramos por lá! PoCT Day MG SBPC/ML 12 de abril de 2025 – das 8 às 18h 📍Hotel Hilton Garden Inn

Presença confirmada no Encontro Anual de Inspetores e Fabricantes de Dispositivos Médicos

A atenção aos aspectos regulatórios é um componente fundamental na estratégia de sucesso de seu produto, da concepção à introdução no mercado, passando por seu desenvolvimento e fabricação. Conte com nossa expertise para uma progressão segura e bem-sucedida através de todos estes desafios. Nos vemos por lá! Encontro Anual de Inspetores e Fabricantes de Dispositivos MédicosPromovido pela Anvisa e pela …

Streamlining Market Entry with Product Registration Hosting

Navigating international markets can be complex, but at WeRegister by Enzytec, we make it seamless for international suppliers. If you don’t have a head office in Brazil, our Product Registration Hosting service is tailored for you.

Unraveling the World of Regulatory Affairs

Have you ever wondered what “regulatory affairs” really means? At WeRegister by Enzytec, we are experts in this vital area that might seem complex at first glance, but is essential for the success of any product in the market.

Presence Confirmed!

We are thrilled to announce that WeRegister by Enzytec will be present at Hospitalar 2024! Join us at one of the most significant healthcare events where we will showcase our latest advancements and solutions in regulatory affairs. WeRegister is dedicated to simplifying the complex regulatory landscape for healthcare and biotechnology products, ensuring compliance and facilitating market entry.

Pleased to Meet You, We Are WeRegister!

After years dedicated to performing exemplary work in the field of regulatory affairs, the Enzytec group is pleased to announce a new chapter: the launch of WeRegister, our brand exclusively specialized in regulatory matters.