{"id":17,"date":"2016-03-14T11:11:45","date_gmt":"2016-03-14T11:11:45","guid":{"rendered":"http:\/\/amcogen.com\/?page_id=17"},"modified":"2017-11-03T08:41:31","modified_gmt":"2017-11-03T08:41:31","slug":"regulatory","status":"publish","type":"page","link":"https:\/\/amcogen.com\/es\/regulatory\/","title":{"rendered":"Asuntos Regulatorios"},"content":{"rendered":"<p><\/p>\n<h2>Registro de Medicamentos | Manejo de consultas regulatorias | Estudios de Bioequivalancia | Documentos GMP (BPM) completamente conformes<\/h2>\n<p>Para apoyar el desarrollo de productos y el programa de cadena de suministro, Amcogen Alliance apoya activamente el registro sanitario del pais. A trav\u00e9s de nuestro equipo de Regulatorio trabajamos estrechamente en l\u00ednea con la gu\u00eda de ISP Chile y tambi\u00e9n con el experto local de regulatorio de Chile, lo que nos permite brindar una asistencia r\u00e1pida y sencilla y una aprobaci\u00f3n regulatoria m\u00e1s r\u00e1pida para los expedientes presentados para hacer las cosas bien en la primera vez.<\/p>\n<h3>Nuestros socios obtienen los siguientes beneficios:<\/h3>\n<ul class=\"checkList\">\n<li>Asesorar sobre el requisito de registro del producto y el dise\u00f1o del estudio de bioequivalencia.<\/li>\n<li>Propocionar lista completa de documentos para el registro del producto y el requisito de registro para que puedan reunirse y decidir qu\u00e9 es exactamente necesario.<\/li>\n<li>Preparar expedientes que cumplan con los requisitos local de la autoridad regulatoria<\/li>\n<li>Implementaci\u00f3n de los requisitos regulatorios<\/li>\n<li>Revision de Expediente y cumplimiento de datos<\/li>\n<li>Manejo de consultas\/observaciones regulatorias<\/li>\n<li>Resolver complejas observacionesregulatorias<\/li>\n<li>Revisi\u00f3n de los documentos GMP<\/li>\n<li>Identificaci\u00f3n de productos potenciales<\/li>\n<li>Estrategias de desarrollo y gesti\u00f3n de proyectos<\/li>\n<\/ul>\n<h3>Desarrollo Cl\u00ednico \/ Estudios de Bioequivalencia para productos gen\u00e9ricos.<\/h3>\n<div class=\"floatList\">\n<ul>\n<li>Revisi\u00f3n del Protocolo y Clinical Study Report (CSR &#8211; Informe del estudio cl\u00ednico)<\/li>\n<li>Revisi\u00f3n de los datos de farmacocin\u00e9tica (PK) de estudios piloto y pivotales<\/li>\n<li>Seguimiento de estudios<\/li>\n<\/ul>\n<ul>\n<li>Auditor\u00eda de sitios y CROs<\/li>\n<li>Asesoramiento y supervisi\u00f3n del cumplimiento<\/li>\n<li>Estrategias para Estudios de BE<\/li>\n<\/ul>\n<\/div>\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>Eliminar las dudas sobre la aprobaci\u00f3n del producto en Chile. Asociarse con nuestro experto asuntos regulatorios y mantener las incertidumbres a un lado.<\/p>\n","protected":false},"author":1,"featured_media":336,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"template-inner.php","meta":{"footnotes":""},"class_list":["post-17","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v15.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<meta name=\"description\" content=\"If you are pharmaceutical company from Latin America and Amcogen.com is actively support your local regulatory registration and regulatory query handling\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/amcogen.com\/es\/regulatory\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" 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