Category: Sem categoria

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

    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 […]

  • Enzytec supports Medmax in Standardizing the Manufacturing of Rapid Immunochromatographic Tests

    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 (

  • 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, […]

  • Enzytec obtains Sanitary Permit for Importation and Distribution of Health Products according to RDC 16/2013 ANVISA

    Enzytec obtains Sanitary Permit for Importation and Distribution of Health Products according to RDC 16/2013 ANVISA

    ENZYTEC NEWS Enzytec obtains Sanitary Permit for Importation and Distribution of Health Products according to RDC 16/2013 ANVISA In April 2022, Enzytec Biotecnologia obtained the Sanitary Permit for Importation and Distribution of Health Products. With long experience in regulatory consulting and technology development, in this new phase the company will also act as a distributor […]

  • RDC 675/22

    ENZYTEC NEWS RDC 675/22 The new RDC 675 came into force in March 2022, which deals with the adequacy of drugs registered until June 2, 2003 and which did not present evidence of therapeutic equivalence at the time of registration. According to ANVISA, RDC 675/22, which revokes RDCs 134/2003, 210/2004, 37/2011 and 98/2016, comes with […]

  • RDC 665/22

    ENZYTEC NEWS RDC 665/22 The new RDC 665 came into force in May 2022, which provides for Good Manufacturing Practices for Medical Products and In Vitro Diagnostic Products, applying to manufacturers, importers and distributors who sell in Brazil. For you who are an entrepreneur in the health market or looking for ways to enter the […]

  • Enzytec develops In Vitro diagnostic reagent for canine Cystatin C detection

    Enzytec develops In Vitro diagnostic reagent for canine Cystatin C detection

    ENZYTEC NEWS Enzytec develops In Vitro diagnostic reagent for canine Cystatin C detection In partnership with the UFMG Veterinary School, the CEO of Enzytec, Dr. Márcio Lacerda, along with Prof. Dr. Fabiola Paes-Leme developed a reagent capable of measuring canine Cystatin C, an early marker in dogs prone to acute kidney injury. To assess the […]

  • Enzytec supports Biotechtown in obtaining ANVISA’s Good Manufacturing Practices for In Vitro Diagnostics

    Enzytec supports Biotechtown in obtaining ANVISA’s Good Manufacturing Practices for In Vitro Diagnostics

    ENZYTEC NEWS Enzytec supports Biotechtown in obtaining ANVISA’s Good Manufacturing Practices for In Vitro Diagnostics Enzytec with its Regulatory Affairs team provided consultancy for the adequacy of the Biotechtown manufacturing unit. At the time, the demand was to make the CMO (Contract Manufacturing Organization) comply with the Good Practices of Control and Manufacturing according to […]

  • Enzytec supports Medmax in obtaining ANVISA’s Good Manufacturing Practices for In Vitro Diagnosis

    Enzytec supports Medmax in obtaining ANVISA’s Good Manufacturing Practices for In Vitro Diagnosis

    ENZYTEC NEWS Enzytec supports Medmax in obtaining ANVISA’s Good Manufacturing Practices for In Vitro Diagnosis Enzytec, with its Regulatory Affairs team, provided consulting services to MEDMAX, a company that produces equipment and reagents for In Vitro diagnostics, with the aim of adapting its manufacturing unit to comply with Good Control and Manufacturing Practices according to […]

  • Enzytec CEO Develops In Vitro Diagnostic Reagent for Early Renal Marker Detection in Dogs

    Enzytec CEO Develops In Vitro Diagnostic Reagent for Early Renal Marker Detection in Dogs

    ENZYTEC NEWS Enzytec CEO Develops In Vitro Diagnostic Reagent for Early Renal Marker Detection in Dogs In partnership with the UFMG Veterinary School, the CEO of Enzytec, Dr. Márcio Lacerda, along with Prof. Dr. Fabiola Paes-Leme developed a reagent capable of interacting with the early marker of acute kidney injury in dogs, the enzyme N-acetyl-β-D-glucosaminidase […]