{"id":5066,"date":"2025-06-01T10:00:00","date_gmt":"2025-06-01T13:00:00","guid":{"rendered":"https:\/\/sobelconsult.com\/inicio\/"},"modified":"2026-06-20T09:02:28","modified_gmt":"2026-06-20T12:02:28","slug":"home","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/pt-br\/","title":{"rendered":"Home"},"content":{"rendered":"\t\t
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Regulat\u00f3rio n\u00e3o \u00e9 burocracia.
\u00c9 vantagem estrat\u00e9gica.<\/span><\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Transforme exig\u00eancias complexas em decis\u00f5es que reduzem riscos, aceleram o acesso ao mercado e conectam conformidade ao crescimento do seu neg\u00f3cio.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tObtenha suporte<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Conta com a confian\u00e7a de empresas que atuam no setor de produtos regulamentados<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\"CMOS<\/figure><\/div>
\"Baruel<\/figure><\/div>
\"Generate<\/figure><\/div>
\"Ortosintese<\/figure><\/div>
\"ZSI<\/figure><\/div>
\"Medtronic<\/figure><\/div>
\"Braun<\/figure><\/div>
\"Hypera<\/figure><\/div>
\"M<\/figure><\/div>
\"Andratec<\/figure><\/div>\t\t\t<\/div>\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Encontre seu caminho regulat\u00f3rio<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Orienta\u00e7\u00f5es claras para o pr\u00f3ximo passo do seu produto.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Dispositivos m\u00e9dicos<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Apoio regulat\u00f3rio estrat\u00e9gico para empresas de dispositivos m\u00e9dicos, desde avalia\u00e7\u00f5es biol\u00f3gicas e cl\u00ednicas at\u00e9 a conformidade ao longo do ciclo de vida e o acesso aos mercados internacionais.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Mercados dispon\u00edveis:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Brasil<\/a><\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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EUA<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Europa<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Canad\u00e1<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Cosm\u00e9ticos<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Suporte regulat\u00f3rio para cosm\u00e9ticos, combinando servi\u00e7os de representa\u00e7\u00e3o com an\u00e1lise de r\u00f3tulos e reivindica\u00e7\u00f5es e muito mais para entrar no mercado em conformidade.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Mercados dispon\u00edveis:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Brasil<\/a><\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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EUA<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Europa<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Canad\u00e1<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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In vitro <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Suporte regulat\u00f3rio para empresas de IVD, atuando como titular do registro e auxiliando na notifica\u00e7\u00e3o e no registro em v\u00e1rias estruturas regulat\u00f3rias.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Mercados dispon\u00edveis:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Brasil<\/a><\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Dispositivos m\u00e9dicos<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Suporte regulat\u00f3rio para dispositivos m\u00e9dicos, com experi\u00eancia em avalia\u00e7\u00f5es biol\u00f3gicas e toxicol\u00f3gicas e consultoria regulat\u00f3ria de ciclo de vida.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Brasil<\/a><\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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EUA<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Europa<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Canad\u00e1<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Cosm\u00e9ticos<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Suporte regulat\u00f3rio para cosm\u00e9ticos, combinando servi\u00e7os de representa\u00e7\u00e3o com an\u00e1lise de r\u00f3tulos e reivindica\u00e7\u00f5es e muito mais para entrar no mercado em conformidade.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Brasil<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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EUA<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Europa<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Canad\u00e1<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Diagn\u00f3stico in vitro<\/span>\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Suporte regulat\u00f3rio para empresas de IVD, atuando como titular do registro e auxiliando na notifica\u00e7\u00e3o e no registro em v\u00e1rias estruturas regulat\u00f3rias.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Brasil<\/a><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Solu\u00e7\u00f5es regulat\u00f3rias projetadas para orientar suas pr\u00f3ximas etapas<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Estrat\u00e9gia regulat\u00f3ria e acesso ao mercado<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Consultoria regulat\u00f3ria estrat\u00e9gica para definir o caminho mais adequado para a entrada no mercado, considerando a classifica\u00e7\u00e3o do produto, os mercados-alvo e os requisitos regulat\u00f3rios.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t

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Servi\u00e7os de representa\u00e7\u00e3o<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Servi\u00e7os de representa\u00e7\u00e3o para dar suporte \u00e0 comunica\u00e7\u00e3o estruturada com autoridades regulat\u00f3rias, incluindo acompanhamento de envios, respostas a solicita\u00e7\u00f5es de autoridades e atividades de liga\u00e7\u00e3o.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t

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Avalia\u00e7\u00e3o biol\u00f3gica e toxicol\u00f3gica<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Consultoria cient\u00edfica e regulat\u00f3ria para seguran\u00e7a biol\u00f3gica e avalia\u00e7\u00f5es toxicol\u00f3gicas, apoiando a avalia\u00e7\u00e3o de riscos e a justificativa regulat\u00f3ria.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t

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Revis\u00e3o de rotulagem, declara\u00e7\u00f5es e conformidade<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Revis\u00e3o regulat\u00f3ria de rotulagem, alega\u00e7\u00f5es e informa\u00e7\u00f5es sobre o produto para garantir o alinhamento com as expectativas regulat\u00f3rias espec\u00edficas do mercado.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t

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Sistemas de gerenciamento de qualidade (QMS)<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Suporte de consultoria para sistemas de gerenciamento de qualidade alinhados com requisitos normativos e padr\u00e3o, apoiando a conformidade, as auditorias e as atividades cont\u00ednuas de qualidade.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t

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Treinamento em regulamenta\u00e7\u00e3o<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Programas estruturados de treinamento regulat\u00f3rio projetados para desenvolver a capacidade interna, fortalecer o entendimento regulat\u00f3rio e apoiar a tomada de decis\u00f5es informadas entre as equipes.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t

\n\t\t\t\t<\/path><\/svg>\t\t\t<\/div>\n\t\t\t
\n\t\t\t\t<\/path><\/svg>\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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A Sobel fornece orienta\u00e7\u00e3o estruturada <\/b>alinhada a cada contexto normativo.<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tComece sua jornada regulat\u00f3ria<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Quem confia em n\u00f3s<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Veja o que nossos clientes est\u00e3o dizendo sobre n\u00f3s<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Estamos satisfeitos com os servi\u00e7os e o suporte regulat\u00f3rio da Sobel Consultancy para a nossa empresa porque eles executam projetos incansavelmente, levando em conta todos os pontos de verifica\u00e7\u00e3o regulat\u00f3rios para garantir que todas as atividades sejam realizadas de maneira \u00e9tica, atingindo o m\u00e1ximo de conformidade e transpar\u00eancia, o que \u00e9 desejado em todos os projetos. A Sobel gerenciou todo o projeto adequadamente e o entregou dentro dos prazos especificados, e recebemos as permiss\u00f5es para nossos IVDs para o mercado brasileiro em tempo h\u00e1bil. <\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t\tLucas Lewis<\/span>MDS - Cingapura<\/span><\/cite>\t\t\t\t<\/div>\n\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t
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Obrigado a voc\u00eas por todo o trabalho \u00e1rduo e dedica\u00e7\u00e3o. Gostaria de destacar o trabalho de voc\u00eas nas \u00faltimas semanas. De modo geral, o resultado do projeto foi fant\u00e1stico, especialmente com todas as dicas e insights valiosos. Todos os nossos fornecedores anteriores n\u00e3o conseguiriam lidar com um projeto regulat\u00f3rio com essa complexidade e com uma rotatividade r\u00e1pida. Obrigado! <\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t\tSophia Gallagher<\/span>TMX Medical - EUA<\/span><\/cite>\t\t\t\t<\/div>\n\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t
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Gostaria de agradecer pessoalmente a Sobel por sua dedica\u00e7\u00e3o e servi\u00e7o profissional. Essa \u00e9 a solu\u00e7\u00e3o perfeita para nossos neg\u00f3cios. <\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t\tEmilia Anderson<\/span>GWA Instruments - EUA<\/span><\/cite>\t\t\t\t<\/div>\n\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t
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Como cliente, tivemos um servi\u00e7o muito amig\u00e1vel e orientado para o objetivo, com solu\u00e7\u00f5es r\u00e1pidas. Esperamos ansiosamente por novos projetos. <\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t\tAndreas Kohl<\/span>AndraTec<\/span><\/cite>\t\t\t\t<\/div>\n\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t
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A Sobel Consultancy foi contratada para um projeto de registro de dispositivo m\u00e9dico para um de nossos produtos exportados e obtivemos o certificado de registro bem antes dos prazos previstos pela empresa. Todo o projeto foi conclu\u00eddo dentro do prazo, com profissionalismo e dentro das nossas expectativas. Estamos muito satisfeitos com todo o desempenho da Sobel e teremos prazer em sugerir seus servi\u00e7os a qualquer pessoa. <\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t\tAbigail Rivera<\/span>Medulha Surgical - M\u00e9xico<\/span><\/cite>\t\t\t\t<\/div>\n\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\u00daltimas novidades<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Informa\u00e7\u00f5es e novidades para te ajudar a lidar com a conformidade com confian\u00e7a.<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\"In<\/div><\/a>\n\t\t\t\t
Cosm\u00e9ticos<\/div>\n\t\t\t\t
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\n\t\t\t\n\t\t\t\tRDC n\u00ba 1.030\/2026: A ANVISA atualiza a lista de subst\u00e2ncias proibidas em cosm\u00e9ticos\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t
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Entenda como a RDC n\u00ba 1.030\/2026 da ANVISA pode afetar as formula\u00e7\u00f5es de cosm\u00e9ticos, os portf\u00f3lios de produtos e os prazos de conformidade regulat\u00f3ria no Brasil.<\/p>\n\t\t<\/div>\n\t\t\t\t\t

\n\t\t\n\t\t\n\t\t\tLeia mais \"\t\t<\/a>\n\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\n\t\t\t19 de junho de 2026\t\t<\/span>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/article>\n\t\t\t\t
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Not\u00edcias<\/div>\n\t\t\t\t
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\n\t\t\t\n\t\t\t\tNot\u00edcias: Sandbox Regulat\u00f3rio da Anvisa e Atualiza\u00e7\u00f5es Globais\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t
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A Anvisa avan\u00e7a em sua iniciativa Sandbox Regulat\u00f3rio para cosm\u00e9ticos personalizados, enquanto os reguladores globais fortalecem a vigil\u00e2ncia p\u00f3s-comercializa\u00e7\u00e3o.<\/p>\n\t\t<\/div>\n\t\t\t\t\t

\n\t\t\n\t\t\n\t\t\tLeia mais \"\t\t<\/a>\n\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\n\t\t\t11 de maio de 2026\t\t<\/span>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/article>\n\t\t\t\t
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Not\u00edcias<\/div>\n\t\t\t\t
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\n\t\t\t\n\t\t\t\tNews: FDA e os dispositivos m\u00e9dicos com intelig\u00eancia artificial\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t
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Saiba mais sobre o marco regulat\u00f3rio da FDA sobre os dispositivos m\u00e9dicos com intelig\u00eancia artificial e mais atualiza\u00e7\u00f5es.<\/p>\n\t\t<\/div>\n\t\t\t\t\t

\n\t\t\n\t\t\n\t\t\tLeia mais \"\t\t<\/a>\n\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\n\t\t\t27 de abril de 2026\t\t<\/span>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/article>\n\t\t\t\t<\/div>\n\t\t\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

Seja parceiro da Sobel e tenha consultoria regulat\u00f3ria especializada. Navegue pelos requisitos globais com confian\u00e7a. Entre em contato com nossa equipe hoje mesmo! <\/p>\n","protected":false},"author":16,"featured_media":7087,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-5066","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"\nConformidade regulamentar: Seu guia para o sucesso<\/title>\n<meta name=\"description\" content=\"Obtenha conformidade regulat\u00f3ria com clareza. 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