{"id":3297,"date":"2014-05-26T22:24:19","date_gmt":"2014-05-26T20:24:19","guid":{"rendered":"http:\/\/www.thema-med.com\/?page_id=16"},"modified":"2014-05-26T22:24:19","modified_gmt":"2014-05-26T20:24:19","slug":"servizi","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/es\/servizi\/","title":{"rendered":"Servicios"},"content":{"rendered":"<p><img decoding=\"async\" class=\"alignleft wp-image-4940 size-medium\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2017\/07\/Strategy-300x200.jpg\" alt=\"\" width=\"300\" height=\"200\" \/><strong>Asesor\u00eda estrat\u00e9gica regulatoria<\/strong><\/p>\n<p>Planificaci\u00f3n de procesos, an\u00e1lisis de las diferencias y evaluaci\u00f3n de la estrategia regulatoria de la empresa.<br \/>\nRedacci\u00f3n de estudios de viabilidad y acuerdos de cualidad t\u00e9cnica.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Registros internacionales <\/strong><\/p>\n<p>Preparaci\u00f3n y env\u00edo del expediente para comercializar, seg\u00fan lo establecido por la normativa y en breve, los productos sanitarios en los Pa\u00edses de inter\u00e9s.<\/p>\n<p>&nbsp;<\/p>\n<p><img decoding=\"async\" class=\"wp-image-4937 size-medium alignleft\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2017\/07\/LR-300x194.png\" alt=\"\" width=\"300\" height=\"194\" \/><strong>Local Representative <\/strong><\/p>\n<p>Calificaci\u00f3n de Thema como Mandatario en la UE y\/o de Thema USA come US Agent en los EE.UU..<br \/>\nLocal Representative internacional, directamente o a trav\u00e9s de Agencias regulatorias locales cualificadas y fiables.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Soporte en la certificaci\u00f3n CE de productos<\/strong><\/p>\n<p>Redacci\u00f3n del expediente t\u00e9cnico para obtener el Marcado CE de producto.<br \/>\nRelaciones con los Organismos Notificados, laboratorios autorizados y otros involucrados.<\/p>\n<p>&nbsp;<\/p>\n<p><img decoding=\"async\" class=\"alignleft wp-image-4647\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2014\/09\/1.jpg\" alt=\"\" width=\"281\" height=\"154\" \/><strong>Registro en Italia y en la UE de dispositivos m\u00e9dicos<\/strong><\/p>\n<p>Env\u00edo de notificaciones de producto seg\u00fan lo requerido por las Autoridades Ministeriales italianas y europeas para registrar dispositivos m\u00e9dicos.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p><strong>GMP internacionales<\/strong><\/p>\n<p>Auditor\u00eda interna y con un servicio de asesor\u00eda y soporte para la implementaci\u00f3n correcta de un Sistema de Gesti\u00f3n de la Calidad en la empresa Cliente.<br \/>\nAyudas en el proceso de adaptaci\u00f3n del Sistema de Gesti\u00f3n de la Calidad de la empresa Cliente a los requisitos de GMP internacionales.<br \/>\nAsistencia durante las inspecciones de Autoridades Regulatorias y\/o otras Autoridades Competentes en las empresas Clientes.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Asesor\u00eda estrat\u00e9gica regulatoria Planificaci\u00f3n de procesos, an\u00e1lisis de las diferencias y evaluaci\u00f3n de la estrategia regulatoria de la empresa. Redacci\u00f3n de  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-3297","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Servicios - Thema - Medical Regulatory Consultancy<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.thema-med.com\/es\/servizi\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Servicios - Thema - Medical Regulatory Consultancy\" \/>\n<meta property=\"og:description\" content=\"Asesor\u00eda estrat\u00e9gica regulatoria Planificaci\u00f3n de procesos, an\u00e1lisis de las diferencias y evaluaci\u00f3n de la estrategia regulatoria de la empresa. 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