{"id":1758,"date":"2026-02-13T08:47:32","date_gmt":"2026-02-13T08:47:32","guid":{"rendered":"https:\/\/utidebio.uk.com\/?page_id=1758"},"modified":"2026-03-27T16:36:04","modified_gmt":"2026-03-27T16:36:04","slug":"cumplimiento-de-la-normativa","status":"publish","type":"page","link":"https:\/\/utidebio.uk.com\/es\/cumplimiento-de-la-normativa\/","title":{"rendered":"Normativa y cumplimiento"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"1758\" class=\"elementor elementor-1758\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-19be0d7 e-con-full e-flex e-con e-parent\" data-id=\"19be0d7\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-458e1a6 elementor-widget elementor-widget-heading\" data-id=\"458e1a6\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Normativa y cumplimiento<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-ed658db e-flex e-con-boxed e-con e-parent\" data-id=\"ed658db\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f5bab74 elementor-widget elementor-widget-woocommerce-breadcrumb\" data-id=\"f5bab74\" data-element_type=\"widget\" data-widget_type=\"woocommerce-breadcrumb.default\">\n\t\t\t\t\t<nav class=\"woocommerce-breadcrumb\" aria-label=\"Breadcrumb\" data-no-translation=\"\" data-trp-gettext=\"\">Inicio<\/nav>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9f09b88 elementor-widget elementor-widget-heading\" data-id=\"9f09b88\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Documentaci\u00f3n reglamentaria, presentaci\u00f3n y revisi\u00f3n<\/h2>\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-bded343 e-con-full e-flex e-con e-child\" data-id=\"bded343\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-91b6303 e-con-full e-flex e-con e-child\" data-id=\"91b6303\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0b5c738 elementor-widget elementor-widget-heading\" data-id=\"0b5c738\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">1. Recopilaci\u00f3n CMC<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6cda3f0 elementor-widget elementor-widget-text-editor\" data-id=\"6cda3f0\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<div data-page-id=\"GJcnd3q9coLLhaxdtSgcRpPfnzd\" data-lark-html-role=\"root\" data-docx-has-block-data=\"false\"><div class=\"ace-line ace-line old-record-id-BdzidQTY6oBw9rxYcK7c9PQTneg\">Se han recopilado y organizado los documentos pertinentes de Qu\u00edmica, Fabricaci\u00f3n y Controles (CMC) para garantizar la exactitud e integridad de los datos, sentando una base s\u00f3lida para el registro del producto y su acceso al mercado.<\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-beac106 e-con-full e-flex e-con e-child\" data-id=\"beac106\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-eed63f5 elementor-widget elementor-widget-heading\" data-id=\"eed63f5\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">2. Recopilaci\u00f3n y presentaci\u00f3n del DMF<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ee42ecb elementor-widget elementor-widget-text-editor\" data-id=\"ee42ecb\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<div data-page-id=\"GJcnd3q9coLLhaxdtSgcRpPfnzd\" data-lark-html-role=\"root\" data-docx-has-block-data=\"false\"><div class=\"ace-line ace-line old-record-id-B2vHdKT5boAi4wxo2S8cVL72nsb\">Los Drug Master Files (DMF) de los API pept\u00eddicos de Utide, Tirzepatide y Retatrutide, han sido aceptados por la FDA estadounidense y figuran oficialmente en la base de datos DMF de la FDA (DMF n\u00ba 042984 y 043330, respectivamente), lo que demuestra nuestro cumplimiento de las normas reguladoras internacionales.<\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6def1a6 e-con-full e-flex e-con e-child\" data-id=\"6def1a6\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6f6e63a elementor-widget elementor-widget-heading\" data-id=\"6f6e63a\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">3. Revisiones anuales de productos<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-746f16d elementor-widget elementor-widget-text-editor\" data-id=\"746f16d\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<div data-page-id=\"GJcnd3q9coLLhaxdtSgcRpPfnzd\" data-lark-html-role=\"root\" data-docx-has-block-data=\"false\"><div class=\"ace-line ace-line old-record-id-AadadiMeVoFZBTxwSDHcJ9nfn2f\">Llevar a cabo revisiones anuales de los productos con regularidad para analizar la calidad de los productos, la conformidad y las reacciones del mercado, ajustar las estrategias con prontitud y garantizar una alineaci\u00f3n sostenida con los requisitos normativos y las demandas del mercado.<\/div><\/div>\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<div class=\"elementor-element elementor-element-0830c74 elementor-widget elementor-widget-image\" data-id=\"0830c74\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"576\" src=\"https:\/\/utidebio.uk.com\/wp-content\/uploads\/2026\/03\/International-Certification-Schedule-1_\u7ed3\u679c-1-1024x576.webp\" class=\"attachment-large size-large wp-image-3095\" alt=\"\" srcset=\"\" sizes=\"(max-width: 1024px) 100vw, 1024px\" data-srcset=\"\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-09cd4e0 elementor-widget elementor-widget-heading\" data-id=\"09cd4e0\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Seg\u00fan el calendario previsto Desarrollo de nuevas instalaciones GMP<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7748cc8 elementor-widget elementor-widget-heading\" data-id=\"7748cc8\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">El desarrollo de nuestra nueva planta de fabricaci\u00f3n GMP avanza seg\u00fan lo previsto como iniciativa estrat\u00e9gica clave.<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-44589e3 elementor-widget elementor-widget-heading\" data-id=\"44589e3\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Hoja de ruta para el desarrollo de instalaciones GMP (previsto)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0c34f6b uael-timeline--center uael-timeline-responsive-tablet uael-timeline-arrow-center elementor-widget elementor-widget-uael-timeline\" data-id=\"0c34f6b\" data-element_type=\"widget\" data-widget_type=\"uael-timeline.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"uael-timeline-wrapper uael-timeline-node\">\n\t\n\t<div class=\"uael-timeline-main\">\n\t\t<div class=\"uael-days\">\n\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-repeater-item-39c0878 uael-timeline-field animate-border out-view\">\n\t\t\t\t\t\t<div class=\"uael-timeline-widget uael-timeline-right\">\n\t\t\t\t\t\t\t<div class=\"uael-timeline-marker\">\n\t\t\t\t\t\t\t\t<span class=\"timeline-icon-new out-view-timeline-icon\">\n\t\t\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fa-calendar\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M12 192h424c6.6 0 12 5.4 12 12v260c0 26.5-21.5 48-48 48H48c-26.5 0-48-21.5-48-48V204c0-6.6 5.4-12 12-12zm436-44v-36c0-26.5-21.5-48-48-48h-48V12c0-6.6-5.4-12-12-12h-40c-6.6 0-12 5.4-12 12v52H160V12c0-6.6-5.4-12-12-12h-40c-6.6 0-12 5.4-12 12v52H48C21.5 64 0 85.5 0 112v36c0 6.6 5.4 12 12 12h424c6.6 0 12-5.4 12-12z\"><\/path><\/svg>\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t<div class=\"uael-day-new uael-day-right\">\n\t\t\t\t\t\t\t\t<div class=\"uael-events-new\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"uael-events-inner-new\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"uael-timeline-date-hide uael-date-inner\"><div class=\"inner-date-new\"><p >Q4 2025<\/p><\/div>\n\t\t\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<div class=\"uael-content\">\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\t\t\t<div class=\"uael-timeline-heading-text\">\n\t\t\t\t\t\t\t\t\t\t\t\t<h3 class=\"uael-timeline-heading\">Fase de preparaci\u00f3n<\/h3>\n\t\t\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\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\t\t\t\t\t<div class=\"uael-timeline-desc-content\"> <div data-page-id=\"GJcnd3q9coLLhaxdtSgcRpPfnzd\" data-lark-html-role=\"root\" data-docx-has-block-data=\"false\"><ol class=\"list-number1\" start=\"1\"><li class=\"ace-line ace-line old-record-id-WsuydC3mYoHziBxUsBwcazI9nsg\" data-list=\"number\"><div>Finalizaci\u00f3n de la ubicaci\u00f3n del centro de fabricaci\u00f3n GMP, con una superficie prevista de aproximadamente 100 000 m\u00b2.<\/div><\/li><li class=\"ace-line ace-line old-record-id-GTVSdhjFdoHwgAxtNlicgDYynsc\" data-list=\"number\"><div>Finalizaci\u00f3n del dise\u00f1o de las instalaciones de conformidad con los requisitos de USP, EP y GMP, incluidas \u00e1reas claramente definidas para los laboratorios de s\u00edntesis, purificaci\u00f3n, liofilizaci\u00f3n y control de calidad.<\/div><\/li><li class=\"ace-line ace-line old-record-id-QO5qdFaYMo9AjDxNVD4crSh7nHd\" data-list=\"number\"><div>Licitaci\u00f3n y nombramiento de un contratista general EPC con cualificaciones y experiencia demostradas en la construcci\u00f3n de instalaciones farmac\u00e9uticas GMP.<\/div><\/li><\/ol><\/div><\/div>\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\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\t\t<div class=\"uael-timeline-arrow\"><\/div>\n\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\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"uael-timeline-date-new\">\n\t\t\t\t\t\t\t\t\t<div class=\"uael-date-new\"><div class=\"inner-date-new\"><div >Q4 2025<\/div><\/div>\n\t\t\t\t\t\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\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-repeater-item-fbd7885 uael-timeline-field animate-border out-view\">\n\t\t\t\t\t\t<div class=\"uael-timeline-widget uael-timeline-left\">\n\t\t\t\t\t\t\t<div class=\"uael-timeline-marker\">\n\t\t\t\t\t\t\t\t<span class=\"timeline-icon-new out-view-timeline-icon\">\n\t\t\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fa-calendar\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M12 192h424c6.6 0 12 5.4 12 12v260c0 26.5-21.5 48-48 48H48c-26.5 0-48-21.5-48-48V204c0-6.6 5.4-12 12-12zm436-44v-36c0-26.5-21.5-48-48-48h-48V12c0-6.6-5.4-12-12-12h-40c-6.6 0-12 5.4-12 12v52H160V12c0-6.6-5.4-12-12-12h-40c-6.6 0-12 5.4-12 12v52H48C21.5 64 0 85.5 0 112v36c0 6.6 5.4 12 12 12h424c6.6 0 12-5.4 12-12z\"><\/path><\/svg>\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t<div class=\"uael-day-new uael-day-left\">\n\t\t\t\t\t\t\t\t<div class=\"uael-events-new\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"uael-events-inner-new\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"uael-timeline-date-hide uael-date-inner\"><div class=\"inner-date-new\"><p >Q1 2026 - Q3 2026<\/p><\/div>\n\t\t\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<div class=\"uael-content\">\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\t\t\t<div class=\"uael-timeline-heading-text\">\n\t\t\t\t\t\t\t\t\t\t\t\t<h3 class=\"uael-timeline-heading\">Fase de construcci\u00f3n<\/h3>\n\t\t\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\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\t\t\t\t\t<div class=\"uael-timeline-desc-content\"> <div data-page-id=\"GJcnd3q9coLLhaxdtSgcRpPfnzd\" data-lark-html-role=\"root\" data-docx-has-block-data=\"false\"><ol class=\"list-number1\" start=\"1\"><li class=\"ace-line ace-line old-record-id-GI4fd6Gs0oU4Bpx9biHcSFn5nnd\" data-list=\"number\"><div>1er trimestre de 2026: Finalizaci\u00f3n de la construcci\u00f3n de las instalaciones principales, incluidas paredes, suelos y techos, utilizando materiales para salas blancas que cumplan las GMP.<\/div><\/li><li class=\"ace-line ace-line old-record-id-LosndgewkobEy3xBqMmc6IennLk\" data-list=\"number\"><div>T2 2026: Instalaci\u00f3n y puesta en marcha de los principales equipos de fabricaci\u00f3n, incluidos:<\/div><ul class=\"list-number2\"><li class=\"ace-line ace-line old-record-id-Ghkbd3o05ok5gix3JUZc3nV8neb\" data-list=\"bullet\"><div>Sistemas de s\u00edntesis pept\u00eddica de 1000 L \u00d73<\/div><\/li><li class=\"ace-line ace-line old-record-id-X35OdsObHoGV36x59kmcRaD1nQc\" data-list=\"bullet\"><div>Sistemas de cromatograf\u00eda DAC-800 \u00d72<\/div><\/li><li class=\"ace-line ace-line old-record-id-DRdVdRex8ooqZIx8EE5cXdgQnjb\" data-list=\"bullet\"><div>Unidades de liofilizaci\u00f3n \u00d72<\/div><\/li><\/ul><\/li><li class=\"ace-line ace-line old-record-id-TljOd94mLo1VNjxKouNc99Tcnwf\" data-list=\"number\"><div>T3 2026: Ejecuci\u00f3n de las actividades de cualificaci\u00f3n de equipos:<\/div><ul class=\"list-number2\"><li class=\"ace-line ace-line old-record-id-GaNTdokwYoxGLQxANNHcZcxjnKb\" data-list=\"number\"><div>Cualificaci\u00f3n de la instalaci\u00f3n (IQ): Verificaci\u00f3n de que la instalaci\u00f3n del equipo cumple las especificaciones de dise\u00f1o y que todos los servicios de apoyo (suministro el\u00e9ctrico, tuber\u00edas, etc.) est\u00e1n correctamente instalados.<\/div><\/li><li class=\"ace-line ace-line old-record-id-BLxJdkhfLoEXebxtqBEcaoSknbd\" data-list=\"number\"><div>Cualificaci\u00f3n operativa (OQ): Verificaci\u00f3n de los par\u00e1metros cr\u00edticos de funcionamiento, como la precisi\u00f3n del control de la temperatura de los sistemas de s\u00edntesis y la estabilidad de la presi\u00f3n de los sistemas de cromatograf\u00eda.<\/div><\/li><li class=\"ace-line ace-line old-record-id-HfY2dJsnWog6bQxwqRbcmNnAnic\" data-list=\"number\"><div>Cualificaci\u00f3n del rendimiento (PQ): Demostraci\u00f3n del rendimiento constante y estable de los equipos mediante lotes de producci\u00f3n simulados.<\/div><\/li><\/ul><\/li><\/ol><\/div><\/div>\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\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\t\t<div class=\"uael-timeline-arrow\"><\/div>\n\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\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"uael-timeline-date-new\">\n\t\t\t\t\t\t\t\t\t<div class=\"uael-date-new\"><div class=\"inner-date-new\"><div >Q1 2026 - Q3 2026<\/div><\/div>\n\t\t\t\t\t\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\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-repeater-item-0b4575c uael-timeline-field animate-border out-view\">\n\t\t\t\t\t\t<div class=\"uael-timeline-widget uael-timeline-right\">\n\t\t\t\t\t\t\t<div class=\"uael-timeline-marker\">\n\t\t\t\t\t\t\t\t<span class=\"timeline-icon-new out-view-timeline-icon\">\n\t\t\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fa-calendar\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M12 192h424c6.6 0 12 5.4 12 12v260c0 26.5-21.5 48-48 48H48c-26.5 0-48-21.5-48-48V204c0-6.6 5.4-12 12-12zm436-44v-36c0-26.5-21.5-48-48-48h-48V12c0-6.6-5.4-12-12-12h-40c-6.6 0-12 5.4-12 12v52H160V12c0-6.6-5.4-12-12-12h-40c-6.6 0-12 5.4-12 12v52H48C21.5 64 0 85.5 0 112v36c0 6.6 5.4 12 12 12h424c6.6 0 12-5.4 12-12z\"><\/path><\/svg>\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t<div class=\"uael-day-new uael-day-right\">\n\t\t\t\t\t\t\t\t<div class=\"uael-events-new\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"uael-events-inner-new\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"uael-timeline-date-hide uael-date-inner\"><div class=\"inner-date-new\"><p >Q4 2026 - Q2 2027<\/p><\/div>\n\t\t\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<div class=\"uael-content\">\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\t\t\t<div class=\"uael-timeline-heading-text\">\n\t\t\t\t\t\t\t\t\t\t\t\t<h3 class=\"uael-timeline-heading\">Puesta en servicio del sistema y fase de arranque de la l\u00ednea de producci\u00f3n<\/h3>\n\t\t\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\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\t\t\t\t\t<div class=\"uael-timeline-desc-content\"> <div data-page-id=\"GJcnd3q9coLLhaxdtSgcRpPfnzd\" data-lark-html-role=\"root\" data-docx-has-block-data=\"false\"><ol class=\"list-number1\" start=\"1\"><li class=\"ace-line ace-line old-record-id-GTq8dgNguowlELx3thocKjN9njb\" data-list=\"number\"><div>4\u00ba trimestre de 2026: Finalizaci\u00f3n de la validaci\u00f3n de los sistemas de climatizaci\u00f3n, agua purificada y aire comprimido, alcanzando los est\u00e1ndares de sala blanca de clase 8.<\/div><\/li><li class=\"ace-line ace-line old-record-id-SucSdG92KoLdYjxDOEIcrQaBnAs\" data-list=\"number\"><div>T1 2027: Finalizaci\u00f3n de la puesta en marcha del proceso, incluidos tres lotes de Semaglutida a escala piloto para verificar la solidez de la l\u00ednea de producci\u00f3n, junto con la validaci\u00f3n de la limpieza.<\/div><\/li><li class=\"ace-line ace-line old-record-id-TVjUdJhlColHx7xxpIdcybKHnEh\" data-list=\"number\"><div>T2 2027: Puesta en marcha oficial de la l\u00ednea de producci\u00f3n, limitada a I+D y fabricaci\u00f3n a escala piloto.<\/div><\/li><\/ol><\/div><\/div>\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\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\t\t<div class=\"uael-timeline-arrow\"><\/div>\n\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\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"uael-timeline-date-new\">\n\t\t\t\t\t\t\t\t\t<div class=\"uael-date-new\"><div class=\"inner-date-new\"><div >Q4 2026 - Q2 2027<\/div><\/div>\n\t\t\t\t\t\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\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-repeater-item-93e71a6 uael-timeline-field animate-border out-view\">\n\t\t\t\t\t\t<div class=\"uael-timeline-widget uael-timeline-left\">\n\t\t\t\t\t\t\t<div class=\"uael-timeline-marker\">\n\t\t\t\t\t\t\t\t<span class=\"timeline-icon-new out-view-timeline-icon\">\n\t\t\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fa-calendar\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M12 192h424c6.6 0 12 5.4 12 12v260c0 26.5-21.5 48-48 48H48c-26.5 0-48-21.5-48-48V204c0-6.6 5.4-12 12-12zm436-44v-36c0-26.5-21.5-48-48-48h-48V12c0-6.6-5.4-12-12-12h-40c-6.6 0-12 5.4-12 12v52H160V12c0-6.6-5.4-12-12-12h-40c-6.6 0-12 5.4-12 12v52H48C21.5 64 0 85.5 0 112v36c0 6.6 5.4 12 12 12h424c6.6 0 12-5.4 12-12z\"><\/path><\/svg>\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t<div class=\"uael-day-new uael-day-left\">\n\t\t\t\t\t\t\t\t<div class=\"uael-events-new\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"uael-events-inner-new\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"uael-timeline-date-hide uael-date-inner\"><div class=\"inner-date-new\"><p >3T 2027 - 1T 2028<\/p><\/div>\n\t\t\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<div class=\"uael-content\">\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\t\t\t<div class=\"uael-timeline-heading-text\">\n\t\t\t\t\t\t\t\t\t\t\t\t<h3 class=\"uael-timeline-heading\">Fase de establecimiento y certificaci\u00f3n del sistema GMP<\/h3>\n\t\t\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\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\t\t\t\t\t<div class=\"uael-timeline-desc-content\"> <div data-page-id=\"GJcnd3q9coLLhaxdtSgcRpPfnzd\" data-lark-html-role=\"root\" data-docx-has-block-data=\"false\"><ol class=\"list-number1\" start=\"1\"><li class=\"ace-line ace-line old-record-id-GSThdcdAao97CExoVxIcddjInLc\" data-list=\"number\"><div>Q3 2027 : Establecimiento de un sistema completo de gesti\u00f3n de la calidad GMP, que abarque el control de la documentaci\u00f3n, la formaci\u00f3n del personal, la gesti\u00f3n de las desviaciones y los procesos de calidad relacionados, al tiempo que se acumulan datos a trav\u00e9s de m\u00faltiples lotes a escala piloto.<\/div><\/li><li class=\"ace-line ace-line old-record-id-GEqIdrd5coCwRCxUZt5cztpanre\" data-list=\"number\"><div>T4 2027: Preparaci\u00f3n y presentaci\u00f3n de los materiales de solicitud de certificaci\u00f3n GMP a la NMPA, incluidos los registros de cualificaci\u00f3n de equipos, la documentaci\u00f3n de procesos y los datos de calidad.<\/div><\/li><li class=\"ace-line ace-line old-record-id-I1J1dzf3VocBYSxZGwNcRJmpnQf\" data-list=\"number\"><div>T1 2028: Apoyo y finalizaci\u00f3n de la inspecci\u00f3n in situ de BPF, con la consecuci\u00f3n prevista de la certificaci\u00f3n de BPF.<\/div><\/li><\/ol><\/div><\/div>\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\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\t\t<div class=\"uael-timeline-arrow\"><\/div>\n\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\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"uael-timeline-date-new\">\n\t\t\t\t\t\t\t\t\t<div class=\"uael-date-new\"><div class=\"inner-date-new\"><div >3T 2027 - 1T 2028<\/div><\/div>\n\t\t\t\t\t\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\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t<div class=\"uael-timeline__line\">\n\t\t\t<div class=\"uael-timeline__line__inner\"><\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\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>","protected":false},"excerpt":{"rendered":"<p>Regulatory &amp; Compliance Regulatory Documentation, Filing &amp; Review 1. CMC Compilation Relevant Chemistry, Manufacturing and Controls (CMC) documents have been [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"no-sidebar","site-content-layout":"","ast-site-content-layout":"full-width-container","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-1758","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/utidebio.uk.com\/es\/wp-json\/wp\/v2\/pages\/1758","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/utidebio.uk.com\/es\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/utidebio.uk.com\/es\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/utidebio.uk.com\/es\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/utidebio.uk.com\/es\/wp-json\/wp\/v2\/comments?post=1758"}],"version-history":[{"count":223,"href":"https:\/\/utidebio.uk.com\/es\/wp-json\/wp\/v2\/pages\/1758\/revisions"}],"predecessor-version":[{"id":3376,"href":"https:\/\/utidebio.uk.com\/es\/wp-json\/wp\/v2\/pages\/1758\/revisions\/3376"}],"wp:attachment":[{"href":"https:\/\/utidebio.uk.com\/es\/wp-json\/wp\/v2\/media?parent=1758"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}