{"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":"conformidade-regulamentar","status":"publish","type":"page","link":"https:\/\/utidebio.uk.com\/pt\/conformidade-regulamentar\/","title":{"rendered":"Regulamenta\u00e7\u00e3o e conformidade"},"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\">Regulamenta\u00e7\u00e3o e conformidade<\/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=\"\">In\u00edcio<\/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\">Documenta\u00e7\u00e3o regulamentar, registo e revis\u00e3o<\/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. Compila\u00e7\u00e3o 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\">Os documentos relevantes de Qu\u00edmica, Fabrico e Controlo (CMC) foram compilados e organizados para garantir a exatid\u00e3o e a integridade dos dados, criando uma base s\u00f3lida para o registo do produto e o acesso ao 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. Compila\u00e7\u00e3o e apresenta\u00e7\u00e3o do 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\">Os Drug Master Files (DMFs) para os APIs de pept\u00eddeos da Utide, Tirzepatide e Retatrutide, foram aceites pela FDA dos EUA e est\u00e3o oficialmente listados na base de dados DMF da FDA (DMF n.\u00ba 042984 e 043330, respetivamente), demonstrando a nossa conformidade com as normas regulamentares internacionais.<\/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. An\u00e1lises anuais de produtos<\/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\">Realizar regularmente revis\u00f5es anuais dos produtos para analisar a qualidade dos produtos, a conformidade e o feedback do mercado, ajustar prontamente as estrat\u00e9gias e garantir um alinhamento sustentado com os requisitos regulamentares e as exig\u00eancias do 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\">Dentro do prazo Desenvolvimento de novas instala\u00e7\u00f5es 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\">O desenvolvimento das nossas novas instala\u00e7\u00f5es de fabrico de BPF est\u00e1 a progredir de acordo com o calend\u00e1rio previsto, constituindo uma iniciativa estrat\u00e9gica fundamental.<\/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\">Roteiro de desenvolvimento de instala\u00e7\u00f5es BPF (planeado)<\/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 prepara\u00e7\u00e3o<\/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>Finaliza\u00e7\u00e3o da localiza\u00e7\u00e3o do local de fabrico GMP, com uma \u00e1rea planeada de aproximadamente 100000 m\u00b2.<\/div><\/li><li class=\"ace-line ace-line old-record-id-GTVSdhjFdoHwgAxtNlicgDYynsc\" data-list=\"number\"><div>Conclus\u00e3o do projeto das instala\u00e7\u00f5es em conformidade com os requisitos da USP, EP e GMP, incluindo \u00e1reas claramente definidas para os laborat\u00f3rios de s\u00edntese, purifica\u00e7\u00e3o, liofiliza\u00e7\u00e3o e CQ.<\/div><\/li><li class=\"ace-line ace-line old-record-id-QO5qdFaYMo9AjDxNVD4crSh7nHd\" data-list=\"number\"><div>Concurso e nomea\u00e7\u00e3o de um empreiteiro geral EPC com qualifica\u00e7\u00f5es e experi\u00eancia comprovadas na constru\u00e7\u00e3o de instala\u00e7\u00f5es farmac\u00eauticas 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 >1\u00ba TRIMESTRE DE 2026 - 3\u00ba TRIMESTRE DE 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 constru\u00e7\u00e3o<\/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>T1 2026: Conclus\u00e3o da constru\u00e7\u00e3o das instala\u00e7\u00f5es principais, incluindo paredes, pavimentos e tectos, utilizando materiais de sala limpa em conformidade com as BPF.<\/div><\/li><li class=\"ace-line ace-line old-record-id-LosndgewkobEy3xBqMmc6IennLk\" data-list=\"number\"><div>Q2 2026: Instala\u00e7\u00e3o e entrada em funcionamento do equipamento de fabrico principal, incluindo:<\/div><ul class=\"list-number2\"><li class=\"ace-line ace-line old-record-id-Ghkbd3o05ok5gix3JUZc3nV8neb\" data-list=\"bullet\"><div>Sistemas de s\u00edntese de p\u00e9ptidos 1000 L \u00d7 3<\/div><\/li><li class=\"ace-line ace-line old-record-id-X35OdsObHoGV36x59kmcRaD1nQc\" data-list=\"bullet\"><div>Sistemas de cromatografia DAC-800 \u00d72<\/div><\/li><li class=\"ace-line ace-line old-record-id-DRdVdRex8ooqZIx8EE5cXdgQnjb\" data-list=\"bullet\"><div>Unidades de liofiliza\u00e7\u00e3o \u00d72<\/div><\/li><\/ul><\/li><li class=\"ace-line ace-line old-record-id-TljOd94mLo1VNjxKouNc99Tcnwf\" data-list=\"number\"><div>T3 2026: Execu\u00e7\u00e3o das actividades de qualifica\u00e7\u00e3o do equipamento:<\/div><ul class=\"list-number2\"><li class=\"ace-line ace-line old-record-id-GaNTdokwYoxGLQxANNHcZcxjnKb\" data-list=\"number\"><div>Qualifica\u00e7\u00e3o da instala\u00e7\u00e3o (IQ): Verifica\u00e7\u00e3o de que a instala\u00e7\u00e3o do equipamento cumpre as especifica\u00e7\u00f5es do projeto e que todos os servi\u00e7os de apoio (alimenta\u00e7\u00e3o el\u00e9ctrica, tubagens, etc.) est\u00e3o corretamente instalados.<\/div><\/li><li class=\"ace-line ace-line old-record-id-BLxJdkhfLoEXebxtqBEcaoSknbd\" data-list=\"number\"><div>Qualifica\u00e7\u00e3o operacional (OQ): Verifica\u00e7\u00e3o de par\u00e2metros operacionais cr\u00edticos, como a precis\u00e3o do controlo da temperatura dos sistemas de s\u00edntese e a estabilidade da press\u00e3o dos sistemas de cromatografia.<\/div><\/li><li class=\"ace-line ace-line old-record-id-HfY2dJsnWog6bQxwqRbcmNnAnic\" data-list=\"number\"><div>Qualifica\u00e7\u00e3o de desempenho (PQ): Demonstra\u00e7\u00e3o do desempenho consistente e est\u00e1vel do equipamento atrav\u00e9s de lotes de produ\u00e7\u00e3o 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 >1\u00ba TRIMESTRE DE 2026 - 3\u00ba TRIMESTRE DE 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 >4T 2026 - 2T 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\">Fase de comissionamento do sistema e arranque da linha de produ\u00e7\u00e3o<\/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>T4 2026: Conclus\u00e3o da valida\u00e7\u00e3o dos sistemas HVAC, \u00e1gua purificada e ar comprimido, atingindo os padr\u00f5es de sala limpa de Classe 8.<\/div><\/li><li class=\"ace-line ace-line old-record-id-SucSdG92KoLdYjxDOEIcrQaBnAs\" data-list=\"number\"><div>T1 2027: Conclus\u00e3o do comissionamento do processo, incluindo tr\u00eas lotes de Semaglutide em escala piloto para verificar a robustez da linha de produ\u00e7\u00e3o, juntamente com a valida\u00e7\u00e3o da limpeza.<\/div><\/li><li class=\"ace-line ace-line old-record-id-TVjUdJhlColHx7xxpIdcybKHnEh\" data-list=\"number\"><div>Q2 2027: Arranque oficial da linha de produ\u00e7\u00e3o, limitada \u00e0 I&amp;D e ao fabrico \u00e0 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 >4T 2026 - 2T 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 >3\u00ba TRIMESTRE DE 2027 - 1\u00ba TRIMESTRE DE 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 Estabelecimento e Certifica\u00e7\u00e3o do Sistema de BPF<\/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 : Estabelecimento de um sistema abrangente de gest\u00e3o da qualidade GMP, abrangendo o controlo da documenta\u00e7\u00e3o, a forma\u00e7\u00e3o do pessoal, a gest\u00e3o dos desvios e os processos de qualidade conexos, ao mesmo tempo que se acumulam dados atrav\u00e9s de v\u00e1rios lotes \u00e0 escala piloto.<\/div><\/li><li class=\"ace-line ace-line old-record-id-GEqIdrd5coCwRCxUZt5cztpanre\" data-list=\"number\"><div>T4 2027: Prepara\u00e7\u00e3o e apresenta\u00e7\u00e3o de materiais de pedido de certifica\u00e7\u00e3o GMP \u00e0 NMPA, incluindo registos de qualifica\u00e7\u00e3o de equipamento, documenta\u00e7\u00e3o de processos e dados de qualidade.<\/div><\/li><li class=\"ace-line ace-line old-record-id-I1J1dzf3VocBYSxZGwNcRJmpnQf\" data-list=\"number\"><div>Q1 2028: Apoio e conclus\u00e3o da inspe\u00e7\u00e3o GMP no local, com a obten\u00e7\u00e3o prevista da certifica\u00e7\u00e3o 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 >3\u00ba TRIMESTRE DE 2027 - 1\u00ba TRIMESTRE DE 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\/pt\/wp-json\/wp\/v2\/pages\/1758","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/utidebio.uk.com\/pt\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/utidebio.uk.com\/pt\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/utidebio.uk.com\/pt\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/utidebio.uk.com\/pt\/wp-json\/wp\/v2\/comments?post=1758"}],"version-history":[{"count":223,"href":"https:\/\/utidebio.uk.com\/pt\/wp-json\/wp\/v2\/pages\/1758\/revisions"}],"predecessor-version":[{"id":3376,"href":"https:\/\/utidebio.uk.com\/pt\/wp-json\/wp\/v2\/pages\/1758\/revisions\/3376"}],"wp:attachment":[{"href":"https:\/\/utidebio.uk.com\/pt\/wp-json\/wp\/v2\/media?parent=1758"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}