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 …
Enzytec: Integrated and Customized Solutions in Regulatory Affairs Read More »
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 …
The Challenges of Product Registration with ANVISA and MAPA: Overcome with Enzytec Read More »
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 …
Unraveling Regulatory Complexity: Raw Material vs Finished Product Read More »
ENZYTEC NEWS Enzytec attends Hacktown 2022 Yesterday was the day to talk about SaMD – Software as Medical Device and how to regularize it! At the invitation of HackTown – the largest innovation and creativity festival in Latin America – Enzytec participated with the lecture “How to certify your medical software at ANVISA”. The theme …
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 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 (
ENZYTEC NEWS Hospitalar 2022 From May 17 to 20, 2022, the 27th edition of Hospitalar took place at São Paulo Expo. In this edition, which was marked by the post-pandemic resumption, we have the support of Anbiotec (National Association of Biotechnology and Life Sciences). During the four days of the fair, we were present at …
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 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 …
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 …