{"id":14319,"date":"2023-05-02T05:40:26","date_gmt":"2023-05-02T05:40:26","guid":{"rendered":"https:\/\/staging.registrarcorp.com\/drugs\/"},"modified":"2025-07-23T08:42:08","modified_gmt":"2025-07-23T08:42:08","slug":"farmacos","status":"publish","type":"page","link":"https:\/\/dev.registrarcorp.com\/es\/industries\/drugs\/","title":{"rendered":"Medicamentos"},"content":{"rendered":"<div class=\"wpb-content-wrapper\">[vc_section full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1743673117657{background-color: #ffffff !important;}&#8221; el_class=&#8221;pt-resp-topmost-section p-resp-section&#8221;][vc_row el_class=&#8221;hero-section d-block d-lg-flex max-breakpoint-md mb-mobile-48&#8243; css=&#8221;.vc_custom_1743774729943{margin-bottom: 96px !important;}&#8221;][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;mb-mobile-48 mb-up-md-64&#8243;][vc_column_text css=&#8221;.vc_custom_1743675077415{margin-bottom: 48px !important;}&#8221; el_class=&#8221;rc-heading-m-resp mb-mobile-32&#8243;]\n<h1 class=\"text-neutral-900\">Cumplimiento farmacol\u00f3gico realizado <span class=\"text-primary-500\">\u2028r\u00e1pido y f\u00e1cil<\/span><\/h1>\n[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743683569114{margin-bottom: 48px !important;}&#8221; fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;25&#8243; grad_text_color1=&#8221;#003873&#8243; el_class=&#8221;rc-body-paragraph-m-resp text-neutral-700 m-width-desktop-580 mb-mobile-32&#8243;]El cumplimiento de la FDA de los EE. UU. no deja margen de error. Registrar Corp es un socio de confianza que ayuda a los fabricantes de f\u00e1rmacos, distribuidores, proveedores de API\/excipientes y marcas OTC a mantener el cumplimiento y garantizar una entrada al mercado sin problemas despu\u00e9s de la aprobaci\u00f3n.[\/vc_column_text][vc_btn title=&#8221;Registrarse ante la FDA&#8221; color=&#8221;primary&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; css=&#8221;.vc_custom_1743775782958{margin-bottom: 0px !important;}&#8221; add_icon=&#8221;true&#8221; link=&#8221;url:https%3A%2F%2Fdev.registrarcorp.com%2Fes%2Fservices%2Ffda-registration%2Fdrugs%2F|&#8221; el_class=&#8221;rc-button-l-resp&#8221;][\/vc_column][vc_column width=&#8221;1\/2&#8243;][vc_video link=&#8221;https:\/\/www.youtube.com\/watch?v=L_7cdADyLY8&#8243; css=&#8221;.vc_custom_1751625450583{margin-bottom: 0px !important;}&#8221; el_class=&#8221;m-width-desktop-560 ms-xl-auto&#8221;][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text css=&#8221;.vc_custom_1743683630763{margin-bottom: 32px !important;}&#8221; el_class=&#8221;rc-heading-s-resp rc-heading&#8211;smaller fw-bolder text-center text-primary-700 m-width-desktop-950 mx-auto&#8221;]\n<h3>Empresas farmac\u00e9uticas l\u00edderes conf\u00edan en Registrar Corp<\/h3>\n[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743683634968{margin-bottom: 64px !important;}&#8221; fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;25&#8243; grad_text_color1=&#8221;#003873&#8243; el_class=&#8221;rc-body-paragraph-m-resp text-neutral-700 mb-mobile-32 m-width-desktop-950 mx-auto&#8221;]Con m\u00e1s de 20 a\u00f1os de experiencia, hemos ayudado a m\u00e1s de 3000 empresas farmac\u00e9uticas a cumplir con la FDA a la primera con el apoyo de expertos.[\/vc_column_text]<div class=\"mpc-carousel__wrapper mpc-waypoint\"><div id=\"mpc_carousel_image-3869de98f4758c6\" class=\"mpc-carousel-image mpc-init mpc-layout--classic mpc-effect--none brand-carousel\"  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class=\"mpc-border\"><\/div><img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"94\" src=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-dsm-firmenich-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"\" title=\"logo-grey-dsm-firmenich\" srcset=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-dsm-firmenich-300x94.webp 300w, https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-dsm-firmenich.webp 420w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/div><\/div><div target=\"\"class=\"mpc-carousel__item-wrapper\" data-height=\"132\"><div onclick=\"\" class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"94\" src=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-dow-corning-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"\" title=\"logo-grey-dow-corning\" srcset=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-dow-corning-300x94.webp 300w, https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-dow-corning.webp 420w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/div><\/div><div target=\"\"class=\"mpc-carousel__item-wrapper\" data-height=\"132\"><div onclick=\"\" class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"94\" src=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-DolceGabanna-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"\" title=\"logo-grey-DolceGabanna\" srcset=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-DolceGabanna-300x94.webp 300w, https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-DolceGabanna.webp 420w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/div><\/div><div target=\"\"class=\"mpc-carousel__item-wrapper\" data-height=\"132\"><div onclick=\"\" class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"94\" src=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Cargill-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"\" title=\"logo-grey-Cargill\" srcset=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Cargill-300x94.webp 300w, https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Cargill.webp 420w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/div><\/div><div target=\"\"class=\"mpc-carousel__item-wrapper\" data-height=\"132\"><div onclick=\"\" class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"94\" src=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Ecolabs-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"\" title=\"logo-grey-Ecolabs\" srcset=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Ecolabs-300x94.webp 300w, https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Ecolabs.webp 420w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/div><\/div><div target=\"\"class=\"mpc-carousel__item-wrapper\" data-height=\"132\"><div onclick=\"\" class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"94\" src=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-gattefosse-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"\" title=\"logo-grey-gattefosse\" srcset=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-gattefosse-300x94.webp 300w, https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-gattefosse.webp 420w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/div><\/div><div target=\"\"class=\"mpc-carousel__item-wrapper\" data-height=\"132\"><div onclick=\"\" class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"94\" src=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Dior-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"\" title=\"logo-grey-Dior\" srcset=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Dior-300x94.webp 300w, https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Dior.webp 420w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/div><\/div><div target=\"\"class=\"mpc-carousel__item-wrapper\" data-height=\"132\"><div onclick=\"\" class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"94\" src=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Walmart-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"\" title=\"logo-grey-Walmart\" srcset=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Walmart-300x94.webp 300w, https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Walmart.webp 420w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/div><\/div><div target=\"\"class=\"mpc-carousel__item-wrapper\" data-height=\"132\"><div onclick=\"\" class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"94\" src=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-MakeUpForever-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"\" title=\"logo-grey-MakeUpForever\" srcset=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-MakeUpForever-300x94.webp 300w, https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-MakeUpForever.webp 420w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/div><\/div><div target=\"\"class=\"mpc-carousel__item-wrapper\" data-height=\"132\"><div onclick=\"\" class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"94\" src=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Fresnenius-Kabi-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"Icon Fresnenius Kabi\" title=\"logo-grey-Fresnenius-Kabi\" srcset=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Fresnenius-Kabi-300x94.webp 300w, https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-Fresnenius-Kabi.webp 420w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/div><\/div><div target=\"\"class=\"mpc-carousel__item-wrapper\" data-height=\"132\"><div onclick=\"\" class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"94\" src=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-AirLiquide-300x94.webp\" class=\"mpc-transition attachment-medium\" alt=\"\" title=\"logo-grey-AirLiquide\" srcset=\"https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-AirLiquide-300x94.webp 300w, https:\/\/dev.registrarcorp.com\/wp-content\/uploads\/2025\/03\/logo-grey-AirLiquide.webp 420w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/div><\/div><\/div><div class=\"mpc-navigation mpc-init mpc-align--left mpc-navigation--style_1  mpc-nav-preset--\" data-mpcslider=\"mpc_carousel_image-3869de98f4758c6\"><div class=\"mpc-nav__arrow mpcslick-prev\"><div class=\"mpc-nav__icon mpc-transition\"><i class=\"\"><div class=\"mpc-nav__background mpc-transition mpc-effect-type--fade mpc-effect-side--in\"><\/div><\/i><\/div><\/div><div class=\"mpc-nav__arrow mpcslick-next\"><div class=\"mpc-nav__icon mpc-transition\"><i class=\"\"><div class=\"mpc-nav__background mpc-transition mpc-effect-type--fade mpc-effect-side--in\"><\/div><\/i><\/div><\/div><\/div><\/div>[\/vc_column][\/vc_row][\/vc_section][vc_section full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1743688713173{background-color: #EEF6FB !important;}&#8221; el_class=&#8221;p-resp-section&#8221;][vc_row][vc_column width=&#8221;1\/3&#8243; el_class=&#8221;mb-mobile-32&#8243;][vc_single_image image=&#8221;53726&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221; css=&#8221;.vc_custom_1748606849501{margin-bottom: 0px !important;}&#8221;][\/vc_column][vc_column width=&#8221;2\/3&#8243;][vc_column_text css=&#8221;.vc_custom_1744049158172{margin-bottom: 48px !important;}&#8221; el_class=&#8221;rc-heading-s-resp rc-heading&#8211;smaller fw-bolder text-center text-md-start text-primary-700 m-width-desktop-720 mx-auto mb-mobile-32&#8243;]\n<h2><span data-teams=\"true\">Su medicamento est\u00e1 listo, pero \u00bfpuede venderlo?<\/span><\/h2>\n[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743701004429{margin-bottom: 0px !important;}&#8221; fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;18&#8243; grad_text_color1=&#8221;#003873&#8243; el_class=&#8221;rc-body-paragraph-m-resp text-primary-700 m-width-desktop-720 mx-auto&#8221;]Su f\u00e1rmaco puede ser autorizado por la FDA, pero si su infraestructura de cumplimiento no lo es, no va a ir a ning\u00fan lugar. Detr\u00e1s de cada producto aprobado se encuentra una compleja cadena de archivos, listados y autorizaciones que deben estar sincronizados antes de poder enviarlos. Un paso perdido y se enfrenta a retenciones fronterizas, rechazos o costosos retrasos. En el mercado actual, el \u00e9xito no se trata solo de obtener la aprobaci\u00f3n, sino de estar realmente preparado para el lanzamiento.[\/vc_column_text][\/vc_column][\/vc_row][\/vc_section][vc_section full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1743688792068{background-color: #FFFFFF !important;}&#8221; el_class=&#8221;p-resp-section&#8221;][vc_row el_class=&#8221;mb-mobile-32&#8243; css=&#8221;.vc_custom_1743688084694{margin-bottom: 96px !important;}&#8221;][vc_column][vc_column_text css=&#8221;.vc_custom_1744049530589{margin-bottom: 0px !important;}&#8221; el_class=&#8221;rc-heading-s-resp rc-heading&#8211;smaller text-center text-primary-700&#8243;]\n<h2>Requisitos estrictos de la FDA simplificados<\/h2>\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row el_class=&#8221;requirement-columns&#8221;][vc_column width=&#8221;1\/5&#8243; el_class=&#8221;requirement-columns__col&#8221;][vc_btn title=&#8221;Requisitos de registro de la FDA&#8221; style=&#8221;flat&#8221; css=&#8221;.vc_custom_1743776491385{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell requirement-columns__header&#8221; link=&#8221;url:https%3A%2F%2Fdev.registrarcorp.com%2Fes%2Fservices%2Ffda-registration%2Fdrugs%2F|&#8221;][vc_column_text css=&#8221;.vc_custom_1744101867070{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Obtenga un n\u00famero DUNS para el registro de la instalaci\u00f3n. Aseg\u00farese de que los datos de DUNS est\u00e9n actualizados si ya tiene un n\u00famero.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1744101880675{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Registre su instalaci\u00f3n y mantenga actualizada la informaci\u00f3n.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1744101910195{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Solicite un c\u00f3digo de etiquetador y enumere sus productos.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1744101942094{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Designe a un agente de EE. UU. si su instalaci\u00f3n se encuentra fuera de EE. UU.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1744101966335{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Complete la autoidentificaci\u00f3n de GDUFA si as\u00ed lo requieren los requisitos de medicamentos gen\u00e9ricos.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1744101979888{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Pague los cargos de GDUFA y OMUFA antes de las fechas de vencimiento, si corresponde.[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/5&#8243; el_class=&#8221;requirement-columns__col&#8221;][vc_btn title=&#8221;Requisitos de la lista de medicamentos&#8221; style=&#8221;flat&#8221; css=&#8221;.vc_custom_1743762911659{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell requirement-columns__header&#8221; link=&#8221;url:https%3A%2F%2Fdev.registrarcorp.com%2Fes%2Findustries%2Fdrugs%2Fservices%2Fproduct-listings%2F|&#8221;][vc_column_text css=&#8221;.vc_custom_1743687267225{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Enumere todos los productos farmacol\u00f3gicos con la FDA antes de su comercializaci\u00f3n.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743687275859{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Reserve un C\u00f3digo Nacional de Medicamentos (NDC) para nuevos productos.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743687284889{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Actualizar o reactivar listados a medida que cambian las formulaciones o los detalles.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743687299066{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Anular la lista de productos que ya no se comercializan.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743687310871{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Notificar las cantidades de f\u00e1rmacos anualmente en virtud de la Ley CARES.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743687379427{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Vuelva a certificar los listados cada a\u00f1o para mantener el cumplimiento.[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/5&#8243; el_class=&#8221;requirement-columns__col&#8221;][vc_btn title=&#8221;Requisitos de etiquetado y certificaci\u00f3n&#8221; style=&#8221;flat&#8221; css=&#8221;.vc_custom_1743768208579{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell requirement-columns__header&#8221; link=&#8221;url:https%3A%2F%2Fdev.registrarcorp.com%2Fes%2Fservices%2Flabel-ingredients-review%2F%23druglabel|&#8221;][vc_column_text css=&#8221;.vc_custom_1743688103633{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Aseg\u00farese de que las etiquetas sean precisas, equilibradas y no enga\u00f1osas.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688112341{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Env\u00ede las etiquetas en formato de etiquetado estructurado de productos (SPL) de la FDA.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688119728{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Siga el formato de panel de datos de f\u00e1rmacos requerido para los f\u00e1rmacos de venta libre.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688126628{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Mantener la coherencia entre todos los componentes de la etiqueta (IP, PIL, \u2028CDS, etc.).[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688136191{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Incluya las advertencias y la informaci\u00f3n de seguridad necesarias.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688149821{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Actualice las etiquetas r\u00e1pidamente para los cambios de seguridad.[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/5&#8243; el_class=&#8221;requirement-columns__col&#8221;][vc_btn title=&#8221;Requisitos de importaci\u00f3n y acceso al mercado&#8221; style=&#8221;flat&#8221; css=&#8221;.vc_custom_1743769043016{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell requirement-columns__header&#8221; link=&#8221;url:https%3A%2F%2Fdev.registrarcorp.com%2Fes%2Fservices%2Fimport-alerts-dwpe%2F|&#8221;][vc_column_text css=&#8221;.vc_custom_1743688161737{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Registre su centro con la FDA antes de importar.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688171498{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Resuelva las alertas de importaci\u00f3n y las detenciones de inmediato.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688179347{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Aseg\u00farese de que los f\u00e1rmacos de venta libre cumplan con los est\u00e1ndares de la monograf\u00eda.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688188003{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Informe de la distribuci\u00f3n anual en virtud de la Ley CARES.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1744809232144{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Informar de las operaciones de licencias de estado 3PL\/WDD.[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/5&#8243; el_class=&#8221;requirement-columns__col&#8221;][vc_btn title=&#8221;Env\u00edo de archivo maestro global&#8221; style=&#8221;flat&#8221; css=&#8221;.vc_custom_1743769068466{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell requirement-columns__header&#8221; link=&#8221;url:https%3A%2F%2Fdev.registrarcorp.com%2Fes%2Fservices%2Fmaster-files%2F%23dmf|&#8221;][vc_column_text css=&#8221;.vc_custom_1743688222175{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Env\u00ede los archivos maestros en formato eCTD seg\u00fan lo requieran la FDA y las agencias globales.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688231243{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Mantenga los archivos actualizados con actualizaciones, modificaciones e informes anuales.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688239829{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Aseg\u00farese de que se presenten cartas de autorizaci\u00f3n (LOA) precisas para las solicitudes de referencia.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688248252{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Cierre o transfiera los archivos correctamente para mantener la alineaci\u00f3n normativa.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688276101{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Almacena y supervisa de forma segura las presentaciones con control de versiones.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688289474{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Responder a las consultas y deficiencias de la agencia de manera oportuna.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688305436{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Alinearse con los est\u00e1ndares t\u00e9cnicos y de formato de cada agencia (FDA, EMA, TGA, etc.).[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743688318328{margin-bottom: 0px !important;}&#8221; el_class=&#8221;requirement-columns__cell&#8221;]Actualice los archivos maestros existentes al formato eCTD 4.0.[\/vc_column_text][\/vc_column][\/vc_row][vc_row el_class=&#8221;mb-mobile-32&#8243; css=&#8221;.vc_custom_1743774037185{margin-bottom: 64px !important;}&#8221;][vc_column][vc_separator css=&#8221;.vc_custom_1743686255954{margin-top: 96px !important;margin-bottom: 96px !important;}&#8221; el_class=&#8221;my-mobile-32&#8243;][vc_column_text css=&#8221;.vc_custom_1743774018694{margin-bottom: 0px !important;}&#8221; el_class=&#8221;rc-heading-s-resp rc-heading&#8211;smaller text-center text-primary-700&#8243;]\n<h2>Formaci\u00f3n en l\u00ednea sobre el cumplimiento de la normativa sobre medicamentos cuando le resulte conveniente<\/h2>\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; equal_height=&#8221;yes&#8221; el_class=&#8221;m-width-desktop-950 mx-auto&#8221;][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;mb-mobile-32&#8243;][vc_single_image image=&#8221;53735&#8243; img_size=&#8221;large&#8221; alignment=&#8221;center&#8221; css=&#8221;.vc_custom_1748606902182{margin-bottom: 0px !important;}&#8221;][\/vc_column][vc_column width=&#8221;1\/2&#8243;][vc_column_text css=&#8221;.vc_custom_1743776824922{margin-bottom: 48px !important;}&#8221; fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;18&#8243; grad_text_color1=&#8221;#003873&#8243; el_class=&#8221;rc-body-paragraph-m-resp text-primary-700 mb-mobile-32&#8243;]Logra la excelencia en los est\u00e1ndares normativos con nuestra formaci\u00f3n de cumplimiento en l\u00ednea.<\/p>\n<p>\u00danete a m\u00e1s de 30 000 profesionales que obtuvieron sus certificados de capacitaci\u00f3n a trav\u00e9s de nuestros cursos de primer nivel impartidos por instructores de clase mundial. Conocimientos expertos accesibles en cualquier momento y lugar.[\/vc_column_text][vc_btn title=&#8221;Explorar capacitaciones&#8221; color=&#8221;primary&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; css=&#8221;.vc_custom_1743769382746{margin-bottom: 0px !important;}&#8221; add_icon=&#8221;true&#8221; link=&#8221;url:https%3A%2F%2Fdev.registrarcorp.com%2Fes%2Fcompliance-training%2Fdrugs%2F|&#8221; el_class=&#8221;rc-button-l-resp&#8221;][\/vc_column][\/vc_row][\/vc_section][vc_section full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1743717130756{background-color: #001C3A !important;}&#8221; el_class=&#8221;p-resp-section blue-gradient-section&#8211;color-bars&#8221;][vc_row content_placement=&#8221;middle&#8221; el_class=&#8221;text-neutral-000&#8243;][vc_column el_class=&#8221;m-width-desktop-1100 mx-auto&#8221;][vc_column_text css=&#8221;.vc_custom_1743699555749{margin-bottom: 48px !important;}&#8221; el_class=&#8221;rc-heading-s-resp rc-heading&#8211;smaller text-center mb-mobile-32&#8243;]\n<h2>Los requisitos de la FDA son complejos, pero facilitamos el cumplimiento.<\/h2>\n[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743700270715{margin-bottom: 48px !important;}&#8221; fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;18&#8243; grad_text_color1=&#8221;#003873&#8243; el_class=&#8221;rc-body-paragraph-m-resp mb-mobile-32&#8243;]<span class=\"text-neutral-000 fw-bold\">Navegar por las normativas sobre medicamentos no tiene por qu\u00e9 ser abrumador. Con los expertos adecuados a su lado, puede garantizar la precisi\u00f3n, evitar retrasos y cumplir con las normas. Permita que Registrar Corp se encargue de sus necesidades de cumplimiento de la FDA.<\/span>[\/vc_column_text][vc_btn title=&#8221;Cumpla hoy mismo&#8221; color=&#8221;primary&#8221; align=&#8221;center&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; css=&#8221;.vc_custom_1743700512574{margin-bottom: 0px !important;}&#8221; add_icon=&#8221;true&#8221; link=&#8221;url:https%3A%2F%2Fdev.registrarcorp.com%2Fes%2Fcontact%2F|&#8221; el_class=&#8221;rc-button-l-resp rc-button&#8211;white&#8221;][\/vc_column][\/vc_row][\/vc_section][vc_section full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1743757252002{background-color: #FFFFFF !important;}&#8221; el_class=&#8221;p-resp-section&#8221;][vc_row el_class=&#8221;mb-mobile-32&#8243; css=&#8221;.vc_custom_1743688084694{margin-bottom: 96px !important;}&#8221;][vc_column css=&#8221;.vc_custom_1743760299430{margin-bottom: 0px !important;}&#8221;][vc_column_text css=&#8221;.vc_custom_1743760265671{margin-bottom: 0px !important;}&#8221; el_class=&#8221;rc-heading-s-resp rc-heading&#8211;smaller text-center text-primary-700&#8243;]\n<h2>Mant\u00e9ngase informado<\/h2>\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row el_class=&#8221;mb-mobile-64&#8243; css=&#8221;.vc_custom_1743774520211{margin-bottom: 96px !important;}&#8221;][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;mb-mobile-32&#8243;][vc_single_image image=&#8221;51608&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221; onclick=&#8221;custom_link&#8221; css=&#8221;.vc_custom_1744043759623{margin-bottom: 0px !important;}&#8221; el_class=&#8221;image-link&#8221; link=&#8221;https:\/\/dev.registrarcorp.com\/es\/blog\/drugs-es\/drug-master-files-es\/submitting-amfs-to-the-uk-mhra\/&#8221;][vc_column_text css=&#8221;.vc_custom_1744043628251{margin-bottom: 0px !important;}&#8221; fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;18&#8243; grad_text_color1=&#8221;#003873&#8243; el_class=&#8221;image-link__overlay image-link__overlay&#8221;]Env\u00edo de ASMF a los medicamentos del Reino Unido \u2028<br class=\"d-none d-md-block\" \/>y Agencia Reguladora de Productos Sanitarios[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/2&#8243;][vc_column_text css=&#8221;.vc_custom_1743757738017{margin-bottom: 32px !important;}&#8221; el_class=&#8221;rc-heading-s-resp rc-heading&#8211;tiny text-primary-700&#8243;]\n<h3>Blogs<\/h3>\n[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743757780417{margin-bottom: 32px !important;}&#8221; fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;18&#8243; grad_text_color1=&#8221;#003873&#8243; el_class=&#8221;rc-body-paragraph-m-resp text-primary-700&#8243;]Explore nuestro blog para obtener las \u00faltimas perspectivas sobre las regulaciones de la FDA, actualizaciones de cumplimiento global, consejos de expertos y m\u00e1s.[\/vc_column_text][vc_btn title=&#8221;Ver todo&#8221; color=&#8221;primary&#8221; align=&#8221;left&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; css=&#8221;.vc_custom_1744103778236{margin-bottom: 0px !important;}&#8221; add_icon=&#8221;true&#8221; link=&#8221;url:%2Fblog%2Ff%C3%A1rmacos%2F|&#8221; el_class=&#8221;rc-button-l-resp rc-button&#8211;blue-outline&#8221;][\/vc_column][\/vc_row][vc_row][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;mb-mobile-32&#8243;][vc_single_image image=&#8221;51169&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221; onclick=&#8221;custom_link&#8221; css=&#8221;.vc_custom_1744103641561{margin-bottom: 0px !important;}&#8221; el_class=&#8221;image-link&#8221; link=&#8221;\/recursos\/seminarios-web-on-demand\/&#8221;][\/vc_column][vc_column width=&#8221;1\/2&#8243;][vc_column_text css=&#8221;.vc_custom_1743757984336{margin-bottom: 32px !important;}&#8221; el_class=&#8221;rc-heading-s-resp rc-heading&#8211;tiny text-primary-700&#8243;]\n<h3>Seminarios web<\/h3>\n[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743757994222{margin-bottom: 32px !important;}&#8221; fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;18&#8243; grad_text_color1=&#8221;#003873&#8243; el_class=&#8221;rc-body-paragraph-m-resp text-primary-700&#8243;]Explore nuestros seminarios web dirigidos por expertos para conocer las \u00faltimas actualizaciones sobre las regulaciones de la FDA, el cumplimiento internacional y los est\u00e1ndares en evoluci\u00f3n del sector.[\/vc_column_text][vc_btn title=&#8221;Ver todo&#8221; color=&#8221;primary&#8221; align=&#8221;left&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; css=&#8221;.vc_custom_1743769527998{margin-bottom: 0px !important;}&#8221; add_icon=&#8221;true&#8221; link=&#8221;url:%2Frecursos%2Fseminarios-web-on-demand%2F|&#8221; el_class=&#8221;rc-button-l-resp rc-button&#8211;blue-outline&#8221;][\/vc_column][\/vc_row][\/vc_section][vc_section full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1743717481112{background-color: #EEF6FB !important;}&#8221; el_class=&#8221;p-resp-section faq-accordion-section&#8221;][vc_row][vc_column][vc_column_text css=&#8221;.vc_custom_1743717888148{margin-bottom: 64px !important;}&#8221; el_class=&#8221;rc-heading-s-resp text-center text-primary-700 mb-mobile-32&#8243;]\n<h2>Preguntas frecuentes sobre el cumplimiento de la FDA en materia de f\u00e1rmacos<\/h2>\n[\/vc_column_text][vc_tta_accordion section_title_tag=&#8221;h2&#8243; c_icon=&#8221;chevron&#8221; active_section=&#8221;1&#8243; no_fill=&#8221;true&#8221; collapsible_all=&#8221;true&#8221; el_class=&#8221;rc-body-paragraph-m-resp text-primary-700&#8243;][vc_tta_section title=&#8221;Para los establecimientos de medicamentos, \u00bfqui\u00e9n debe registrarse?&#8221; tab_id=&#8221;who-must-register&#8221; el_class=&#8221;accordion-class&#8221;][vc_column_text fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;24&#8243; grad_text_color1=&#8221;#003873&#8243;]Los propietarios u operadores nacionales o extranjeros de establecimientos que fabrican, preparan, propagan, componen o procesan un medicamento o f\u00e1rmacos y no se consideran exentos deben registrar sus instalaciones ante la FDA, de acuerdo con <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-C\/part-207\/subpart-B\/section-207.17\" target=\"_blank\" rel=\"noopener\">el C\u00f3digo de Regulaciones Federales<\/a>. En general, las exenciones incluyen farmacias, profesionales con licencia, investigadores, maestros, analistas y distribuidores.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;\u00bfQu\u00e9 informaci\u00f3n se requiere para el registro del establecimiento de medicamentos?&#8221; tab_id=&#8221;what-information-is-required&#8221; el_class=&#8221;accordion-class&#8221;][vc_column_text]<span data-contrast=\"auto\">La informaci\u00f3n que debe enviar como parte del registro de su instalaci\u00f3n de la FDA con su archivo de Etiquetado Estructurado de Productos (Structured Product Labeling, SPL) incluye:<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\"><\/span><\/p>\n<ul>\n<li data-leveltext=\"\u25cf\" data-font=\"Calibri\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Nombre de la compa\u00f1\u00eda y direcci\u00f3n completa de cada establecimiento<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Calibri\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Nombre, direcci\u00f3n, n\u00famero de tel\u00e9fono y direcci\u00f3n de correo electr\u00f3nico del contacto oficial<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Calibri\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Tipo de operaci\u00f3n(s) realizada en cada establecimiento<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Calibri\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">N\u00famero DUNS<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Calibri\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Identificador de establecimiento de la instalaci\u00f3n (cuando se asigne)<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">No. Los establecimientos de los EE. UU. tambi\u00e9n deben incluir:<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\"><\/span><\/p>\n<ul>\n<li data-leveltext=\"\u25cf\" data-font=\"Calibri\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Nombre del agente de EE. UU. designado<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Calibri\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Nombre de cada importador conocido por el establecimientoNombre de cada agente, corredor u otra entidad, que no sea un transportista utilizado para facilitar la importaci\u00f3n de su medicamento a los EE. UU.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Calibri\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Incluya el n\u00famero DUNS, el n\u00famero de tel\u00e9fono y la direcci\u00f3n de correo electr\u00f3nico para cada entrada.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">Consulte el <\/span><a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-C\/part-207\/subpart-B\/section-207.25\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">T\u00edtulo 21 del C\u00f3digo de Regulaciones Federales<\/span><\/a><span data-contrast=\"auto\"> para obtener una lista completa.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\"><\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;\u00bfQui\u00e9n debe proporcionar listas de medicamentos?&#8221; tab_id=&#8221;who-must-provide-drug-listings&#8221; el_class=&#8221;accordion-class&#8221;][vc_column_text]<span data-contrast=\"auto\">Todos los establecimientos de medicamentos que no se consideren exentos y que deban registrarse ante la FDA tambi\u00e9n deben presentar la informaci\u00f3n de listado inicial de todos los medicamentos en distribuci\u00f3n comercial al momento del registro original en sus instalaciones de la FDA, de acuerdo con <\/span><a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-C\/part-207\/subpart-D\/section-207.41\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">el C\u00f3digo de Regulaciones Federales<\/span><\/a><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\"><\/span><\/p>\n<p><span data-contrast=\"auto\">En general, las exenciones incluyen farmacias, profesionales con licencia, investigadores, maestros, analistas y distribuidores.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\"><\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;\u00bfQu\u00e9 informaci\u00f3n se env\u00eda para una lista de medicamentos?&#8221; tab_id=&#8221;what-information-is-submitted&#8221; el_class=&#8221;accordion-class&#8221;][vc_column_text]<span data-contrast=\"auto\">La informaci\u00f3n que debe presentar como parte de su lista de f\u00e1rmacos de la FDA incluye:<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\"><\/span><\/p>\n<ul>\n<li data-leveltext=\"\u25cf\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Nombre del establecimiento(s) que fabrica o procesa el f\u00e1rmaco enumerado y el tipo de operaci\u00f3n(s) realizada<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Cronograma de la DEA<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">V\u00eda(s) de administraci\u00f3n<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Forma farmac\u00e9utica<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Ingredientes (activos con cantidades de concentraci\u00f3n e inactivos)<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559685&quot;:720,&quot;335559737&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Informaci\u00f3n de marketing (p. ej., categor\u00eda, fecha de inicio\/finalizaci\u00f3n)<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Informaci\u00f3n relacionada con la solicitud (p. ej., tipo y a\u00f1o de aprobaci\u00f3n) o n\u00famero de cita de la monograf\u00eda de OTC<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Tama\u00f1o y tipo de paquete<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">C\u00f3digo de producto NDC para un f\u00e1rmaco fuente reenvasado o reetiquetado<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Identificadores \u00fanicos de ingredientes (UNII) y otros conjuntos de c\u00f3digos<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Caracter\u00edsticas distintivas de ciertos f\u00e1rmacos enumerados<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Arte de etiquetado<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559685&quot;:720,&quot;335559737&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/span><\/li>\n<li data-leveltext=\"\u25cf\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\u25cf&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">N\u00famero del C\u00f3digo Nacional de Medicamentos (National Drug Code, NDC)<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559685&quot;:720,&quot;335559737&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:276,&quot;335559991&quot;:360}\"><\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">Consulte <\/span><a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-C\/part-207\/subpart-D\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">el C\u00f3digo de Regulaciones Federales<\/span><\/a><span data-contrast=\"auto\"> para obtener m\u00e1s detalles.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\"><\/span>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;\u00bfQu\u00e9 es un archivo maestro?&#8221; tab_id=&#8221;what-is-a-master-file&#8221; el_class=&#8221;accordion-class&#8221;][vc_column_text]<span data-contrast=\"auto\">Un archivo <\/span><a href=\"https:\/\/www.registrarcorp.com\/master-files\/\"><span data-contrast=\"none\"><\/span><\/a><span data-contrast=\"auto\"> maestro es una presentaci\u00f3n segura y confidencial de datos de productos de propiedad exclusiva a una agencia reguladora, como la Administraci\u00f3n de Alimentos y Medicamentos (Food and Drug Administration, FDA) de los EE. UU. o la Asociaci\u00f3n Nacional de Productos M\u00e9dicos (National Medical Products Association, NMPA) en China.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559740&quot;:276}\"><\/span>[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][\/vc_section][vc_section full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1743716164337{background-color: #003873 !important;}&#8221; el_class=&#8221;p-resp-section p-resp-section&#8211;smaller blue-gradient-section&#8211;color-bars&#8221;][vc_row content_placement=&#8221;middle&#8221; el_class=&#8221;text-neutral-000&#8243;][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;m-width-desktop-1100 mx-auto order-last order-md-first&#8221;][vc_column_text css=&#8221;.vc_custom_1743775092024{margin-bottom: 64px !important;}&#8221; el_class=&#8221;rc-heading-m-resp mb-mobile-32&#8243;]\n<h2>Lograr un mejor f\u00e1rmaco <br class=\"d-none d-xl-block\" \/>cumplimiento f\u00e1cilmente<\/h2>\n[\/vc_column_text][vc_btn title=&#8221;Comience&#8221; color=&#8221;primary&#8221; align=&#8221;left&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; css=&#8221;.vc_custom_1743775801447{margin-bottom: 0px !important;}&#8221; add_icon=&#8221;true&#8221; link=&#8221;url:https%3A%2F%2Fdev.registrarcorp.com%2Fes%2Fservices%2Ffda-registration%2Fdrugs%2F|&#8221; el_class=&#8221;rc-button-l-resp rc-button&#8211;bg-white&#8221;][\/vc_column][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;order-first order-md-last mb-mobile-32&#8243;][vc_single_image image=&#8221;53744&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221; css=&#8221;.vc_custom_1748606953543{margin-bottom: 0px !important;}&#8221;][\/vc_column][\/vc_row][\/vc_section]\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_section full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1743673117657{background-color: #ffffff !important;}&#8221; el_class=&#8221;pt-resp-topmost-section p-resp-section&#8221;][vc_row el_class=&#8221;hero-section d-block d-lg-flex max-breakpoint-md mb-mobile-48&#8243; css=&#8221;.vc_custom_1743774729943{margin-bottom: 96px !important;}&#8221;][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;mb-mobile-48 mb-up-md-64&#8243;][vc_column_text css=&#8221;.vc_custom_1743675077415{margin-bottom: 48px !important;}&#8221; el_class=&#8221;rc-heading-m-resp mb-mobile-32&#8243;] Cumplimiento farmacol\u00f3gico realizado \u2028r\u00e1pido y f\u00e1cil [\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1743683569114{margin-bottom: 48px !important;}&#8221; fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;25&#8243; grad_text_color1=&#8221;#003873&#8243; el_class=&#8221;rc-body-paragraph-m-resp text-neutral-700 m-width-desktop-580 mb-mobile-32&#8243;]El cumplimiento de la FDA de los EE. UU. no deja margen de error. Registrar Corp<\/p>\n","protected":false},"author":33,"featured_media":0,"parent":14838,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-templates\/page-sidebar-none.php","meta":{"_acf_changed":false,"content-type":"","footnotes":""},"class_list":["post-14319","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.registrarcorp.com\/es\/wp-json\/wp\/v2\/pages\/14319","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dev.registrarcorp.com\/es\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/dev.registrarcorp.com\/es\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/dev.registrarcorp.com\/es\/wp-json\/wp\/v2\/users\/33"}],"replies":[{"embeddable":true,"href":"https:\/\/dev.registrarcorp.com\/es\/wp-json\/wp\/v2\/comments?post=14319"}],"version-history":[{"count":0,"href":"https:\/\/dev.registrarcorp.com\/es\/wp-json\/wp\/v2\/pages\/14319\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/dev.registrarcorp.com\/es\/wp-json\/wp\/v2\/pages\/14838"}],"wp:attachment":[{"href":"https:\/\/dev.registrarcorp.com\/es\/wp-json\/wp\/v2\/media?parent=14319"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}