{"id":11202,"date":"2025-08-01T16:17:27","date_gmt":"2025-08-01T19:17:27","guid":{"rendered":"https:\/\/sobelconsult.com\/fda-safety-substantiation-for-cosmetics-mocra-expediente-de-seguridad-del-producto\/"},"modified":"2025-09-16T11:33:00","modified_gmt":"2025-09-16T14:33:00","slug":"fda-safety-substantiation-for-cosmetics-mocra-product-safety-dossier","status":"publish","type":"page","link":"https:\/\/sobelconsult.com\/es\/fda-safety-substantiation-for-cosmetics-mocra-product-safety-dossier\/","title":{"rendered":"FDA Safety Substantiation for Cosmetics | MoCRA Expediente de seguridad del producto"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"11202\" class=\"elementor elementor-11202\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f2c473c e-flex e-con-boxed e-con e-parent\" data-id=\"f2c473c\" data-element_type=\"container\" data-e-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-7c2dd78 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"7c2dd78\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Sustentaci\u00f3n de la seguridad de los cosm\u00e9ticos<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8d024c0 elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"8d024c0\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"To commercialize in the U.S. market, cosmetic companies must demonstrate the safety of their products with solid documentation. Sobel supports you by compiling scientific data, studies, and analyses into a compliant FDA safety substantiation file\u2014aligned with MoCRA and inspection-ready for the FDA.\"}]\" data-inline-monday=\"true\">Para comercializar en el mercado estadounidense, las empresas cosm\u00e9ticas deben demostrar la seguridad de sus productos con documentaci\u00f3n s\u00f3lida. Sobel te ayuda recopilando datos cient\u00edficos, estudios y an\u00e1lisis en un expediente de justificaci\u00f3n de seguridad conforme a la FDA, alineado con la MoCRA y listo para la inspecci\u00f3n de la FDA. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f3d0160 elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"f3d0160\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6ODQyNCwidG9nZ2xlIjpmYWxzZX0%3D\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Consigue ayuda de expertos<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\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<div class=\"elementor-element elementor-element-a9a3ee3 e-flex e-con-boxed e-con e-parent\" data-id=\"a9a3ee3\" data-element_type=\"container\" data-e-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<div class=\"elementor-element elementor-element-0ea06bc e-con-full e-flex e-con e-child\" data-id=\"0ea06bc\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-559b55e e-con-full e-transform e-flex e-con e-child\" data-id=\"559b55e\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation_mobile&quot;:&quot;fadeIn&quot;,&quot;_transform_translateX_effect&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:96,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:0,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:-109,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-df010b0 elementor-widget elementor-widget-heading\" data-id=\"df010b0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<span class=\"elementor-heading-title elementor-size-default\">\u00bfPara qui\u00e9n?<\/span>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-99b5842 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"99b5842\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e0884f4 elementor-align-end elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"e0884f4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Fabricantes de cosm\u00e9ticos y propietarios de marcas que venden en EE.UU.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Empresas extranjeras que exportan cosm\u00e9ticos al mercado estadounidense.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Empresas que se preparan para las inspecciones de la FDA en virtud de la MoCRA.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Empresas que carecen de documentaci\u00f3n de seguridad completa u organizada.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\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>\n\t\t<div class=\"elementor-element elementor-element-a3bb71b e-con-full e-flex e-con e-child\" data-id=\"a3bb71b\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation_mobile&quot;:&quot;fadeIn&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4d12861 elementor-widget elementor-widget-image\" data-id=\"4d12861\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"755\" height=\"1024\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/section-fundo-755x1024.png\" class=\"attachment-large size-large wp-image-13866\" alt=\"Cosmetic products in amber bottles. Regulatory Affairs Cosmetics.\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/section-fundo-755x1024.png 755w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/section-fundo-221x300.png 221w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/section-fundo-768x1041.png 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/section-fundo.png 1011w\" sizes=\"(max-width: 755px) 100vw, 755px\" \/>\t\t\t\t\t\t\t\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\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-fa56660 e-flex e-con-boxed e-con e-parent\" data-id=\"fa56660\" data-element_type=\"container\" data-e-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-6385bc5 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"6385bc5\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Count on Sobel to prepare your FDA safety substantiation file, compiling scientific data, studies, and analyses into a structured dossier that demonstrates your cosmetic product is safe and compliant with MoCRA.\"}]\" data-inline-monday=\"true\">Cuenta con Sobel para preparar tu expediente de justificaci\u00f3n de seguridad ante la FDA, recopilando datos cient\u00edficos, estudios y an\u00e1lisis en un expediente estructurado que demuestre que tu producto cosm\u00e9tico es seguro y cumple la MoCRA.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-72652bd elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"72652bd\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6ODQyNCwidG9nZ2xlIjpmYWxzZX0%3D\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">\u00a1Consigue apoyo!<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\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<div class=\"elementor-element elementor-element-69c8b68 e-flex e-con-boxed e-con e-parent\" data-id=\"69c8b68\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8f93cb7 elementor-widget-mobile__width-inherit elementor-widget elementor-widget-image\" data-id=\"8f93cb7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1803\" height=\"278\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/sec-cosmetics.png\" class=\"attachment-full size-full wp-image-13878\" alt=\"Shape pink\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/sec-cosmetics.png 1803w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/sec-cosmetics-300x46.png 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/sec-cosmetics-1024x158.png 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/sec-cosmetics-768x118.png 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/sec-cosmetics-1536x237.png 1536w\" sizes=\"(max-width: 1803px) 100vw, 1803px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-266a278 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"266a278\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">\u00bfPor qu\u00e9 necesitas este servicio?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9686647 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"9686647\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-02a8896 e-con-full e-flex e-con e-child\" data-id=\"02a8896\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6e6bfbf elementor-widget elementor-widget-text-editor\" data-id=\"6e6bfbf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"MoCRA requires every cosmetic sold in the U.S. to have documented safety substantiation available for FDA review.\"}]\" data-inline-monday=\"true\">La MoCRA exige que todos los cosm\u00e9ticos vendidos en EE.UU. tengan una justificaci\u00f3n de seguridad documentada disponible para su revisi\u00f3n por la FDA.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-f9aa0f2 e-con-full e-flex e-con e-child\" data-id=\"f9aa0f2\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6449a9e elementor-widget elementor-widget-text-editor\" data-id=\"6449a9e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Missing or poorly structured data increases the risk of detentions, recalls, and regulatory enforcement.\"}]\" data-inline-monday=\"true\">Los datos que faltan o est\u00e1n mal estructurados aumentan el riesgo de inmovilizaciones, retiradas y aplicaci\u00f3n de la normativa.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2612897 e-con-full e-flex e-con e-child\" data-id=\"2612897\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4b110a1 elementor-widget elementor-widget-text-editor\" data-id=\"4b110a1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Comprehensive documentation ensures your products are inspection-ready and strengthens trust with consumers.\"}]\" data-inline-monday=\"true\">Una documentaci\u00f3n exhaustiva garantiza que tus productos est\u00e1n listos para la inspecci\u00f3n y refuerza la confianza de los consumidores.<\/p>\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>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-154721b e-flex e-con-boxed e-con e-parent\" data-id=\"154721b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-0f100f3 e-con-full e-flex e-con e-child\" data-id=\"0f100f3\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-27b3607 elementor-widget__width-initial elementor-widget-laptop__width-initial elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"27b3607\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">C\u00f3mo apoya Sobel tu justificaci\u00f3n de seguridad ante la FDA<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-55d8f6f e-con-full e-flex e-con e-child\" data-id=\"55d8f6f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e5ab572 elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"e5ab572\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Una s\u00f3lida justificaci\u00f3n de la seguridad va m\u00e1s all\u00e1 de la recopilaci\u00f3n de documentos: requiere experiencia reguladora y una presentaci\u00f3n cient\u00edfica clara.<\/p>\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\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2a6503d e-flex e-con-boxed e-con e-parent\" data-id=\"2a6503d\" data-element_type=\"container\" data-e-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-3936b26 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"3936b26\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Con Sobel, la creaci\u00f3n de tu expediente de justificaci\u00f3n de seguridad ante la FDA se convierte en algo estructurado, eficaz y conforme a la normativa.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bca4ab5 elementor-widget elementor-widget-ucaddon_horizontal_timeline\" data-id=\"bca4ab5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"ucaddon_horizontal_timeline.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\n<!-- start Horizontal Timeline -->\n\t\t<link id='font-awesome-css' href='https:\/\/sobelconsult.com\/wp-content\/plugins\/unlimited-elements-for-elementor-premium\/assets_libraries\/font-awesome6\/fontawesome-all.min.css' type='text\/css' rel='stylesheet' >\n\t\t<link id='font-awesome-4-shim-css' href='https:\/\/sobelconsult.com\/wp-content\/plugins\/unlimited-elements-for-elementor-premium\/assets_libraries\/font-awesome6\/fontawesome-v4-shims.min.css' type='text\/css' rel='stylesheet' >\n\t\t<link id='owl-carousel-css' href='https:\/\/sobelconsult.com\/wp-content\/plugins\/unlimited-elements-for-elementor-premium\/assets_libraries\/owl-carousel-new\/assets\/owl.carousel.css' type='text\/css' rel='stylesheet' >\n\n<style>\/* widget: Horizontal Timeline *\/\n\n#uc_horizontal_timeline_elementor_bca4ab5 *{\n  box-sizing:border-box;\n}\n\n#uc_horizontal_timeline_elementor_bca4ab5{\n  position:relative;\n  min-height:1px;\n}\n\n#uc_horizontal_timeline_elementor_bca4ab5 .ue-carousel-content{\n    display: flex;\n    flex-flow: column nowrap;\n    flex:1;\n}\n\n#uc_horizontal_timeline_elementor_bca4ab5 .ue-carousel-item{\n  overflow:hidden;\n  position:relative;\n  display:flex;\n}\n\n#uc_horizontal_timeline_elementor_bca4ab5 .ue-btn-holder{\n  margin-top:auto;\n}\n\n#uc_horizontal_timeline_elementor_bca4ab5 .ue-btn{\n  text-align:center;\n  text-decoration:none;\n  transition:0.3s;\n} \n\n#uc_horizontal_timeline_elementor_bca4ab5 .item-horizontal-timeline .ue-item-title{\n  font-size:21px;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_bca4ab5 .carousel-nav{\n  position:relative;\n  z-index:10;\n}\n\n#uc_horizontal_timeline_elementor_bca4ab5 .carousel-nav .carousel-prev{\n    position:absolute;\n      display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_bca4ab5 .carousel-nav .carousel-next{\n  position:absolute;\n  display:inline-block;    \n}\n\n#uc_horizontal_timeline_elementor_bca4ab5  .carousel-nav button svg, \n#uc_horizontal_timeline_elementor_bca4ab5  .carousel-nav button i{\n  position: absolute;\n     top: 50%;\n  left: 50%;\n  transform: translate(-50%, -50%);\n}\n\n#uc_horizontal_timeline_elementor_bca4ab5 .owl-dots {\n  overflow:hidden;\n  display:true !important;  \n}\n\n#uc_horizontal_timeline_elementor_bca4ab5 .owl-dot {\n  border-radius:50%;\n  display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_bca4ab5 .ue-item-bullet-holder{\n  display:flex;\n  align-items:center;\n}\n\n#uc_horizontal_timeline_elementor_bca4ab5 .ue-item-bullet-line{\n  flex-grow:1;\n}\n\n#uc_horizontal_timeline_elementor_bca4ab5 .ue-item-bullet-line-spacing{\n  flex-grow:0;\n  flex-shrink:0;\n}\n\n#uc_horizontal_timeline_elementor_bca4ab5 .ue-item-bullet{\n  position:relative;\n  transition: all .3s ease;\n}\n\n#uc_horizontal_timeline_elementor_bca4ab5 .ue-item-bullet i, #uc_horizontal_timeline_elementor_bca4ab5 .ue-item-bullet svg{\n  position: absolute;\n  top: 50%;\n  left: 50%;\n  transform: translate(-50%, -50%); \n}\n\n#uc_horizontal_timeline_elementor_bca4ab5 .ue-item-label a{\n  font-size:12px;\n  line-height:1.5em;\n  text-decoration:none;\n}\n\n#uc_horizontal_timeline_elementor_bca4ab5 .ue-item-image{\n  overflow:hidden;\n}\n\n#uc_horizontal_timeline_elementor_bca4ab5 .ue-item-image a{\n  display:block;\n}\n\n#uc_horizontal_timeline_elementor_bca4ab5 .ue-item-image img{\n  object-fit: cover;\n  width:100%;\n  transition:0.3s;\n}\n\n#uc_horizontal_timeline_elementor_bca4ab5 .ue-item-vertical-line-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_bca4ab5 .ue-item-pointer-holder{\n  display:flex;\n  justify-content:center; \n}\n\n#uc_horizontal_timeline_elementor_bca4ab5 .ue-carousel-item:hover .ue-item-image img{\n  transform:scale(1.1,1.1);\n}\n\n#uc_horizontal_timeline_elementor_bca4ab5 .ue-item-label{\n display:inline-block;\n}\n\n#uc_horizontal_timeline_elementor_bca4ab5 .ue-carousel-item-holder{\n  display: flex;\n  flex-direction: column;\n  align-items: stretch;\n  height:100%;\n}\n\n<\/style>\n\n<div class=\"ue-horizontal-timeline\" id=\"uc_horizontal_timeline_elementor_bca4ab5\">\n     <div class=\"carousel-nav\">\n            <button class=\"carousel-prev\" aria-label=\"Previous\">\n                <i class=' ti-arrow-circle-left'><\/i>\n            <\/button>\n            <button class=\"carousel-next\" aria-label=\"Next\">\n                <i class=' ti-arrow-circle-right'><\/i>\n            <\/button>\n        <\/div>\n    <div class=\"owl-carousel owl-theme uc-items-wrapper item-horizontal-timeline  \" id=\"uc_horizontal_timeline_elementor_bca4ab5\" data-custom-sethtml=\"true\"  >\n     \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-3a2bbde\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Obtenci\u00f3n y revisi\u00f3n de datos<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Identificamos y evaluamos todos los datos de seguridad disponibles sobre los ingredientes y la formulaci\u00f3n de tu producto.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-707867f\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Integraci\u00f3n cient\u00edfica<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Se revisan e incluyen los estudios toxicol\u00f3gicos pertinentes, los an\u00e1lisis de expertos y la bibliograf\u00eda.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-14b2401\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Montaje de expedientes<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Todas las pruebas se recopilan en un expediente estructurado de justificaci\u00f3n de la seguridad conforme a las normas MoCRA.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-1b6cead\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >An\u00e1lisis de carencias<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">Destacamos la documentaci\u00f3n que falta o es insuficiente y recomendamos medidas correctoras.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n \n\n\n<div class=\"ue-carousel-item elementor-repeater-item-44aaf39\">\n    <div class=\"ue-item-bullet-holder\">\n    <div class=\"ue-item-bullet-line\"><\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet\">\n      <i class='lnr lnr-checkmark-circle'><\/i>          <\/div>\n    <div class=\"ue-item-bullet-line-spacing\"><\/div>\n    <div class=\"ue-item-bullet-line\"><\/div>\n  <\/div>\n\n   \n\n    <div class=\"ue-item-vertical-line-holder\">\n    <div class=\"ue-item-vertical-line\"><\/div>\n  <\/div>\n    \n    <div class=\"ue-item-pointer-holder\">\n    <div class=\"ue-item-pointer\"><\/div>\n  <\/div>\n    \n   <div class=\"ue-carousel-item-holder\">\n    \n          <div class=\"ue-carousel-content\">\n        <div class=\"ue-carousel-content-inside\">\n                    <div class=\"ue-item-title\">\n            <a href=\"#\" >Informe Justificativo de Seguridad<\/a>\n          <\/div>\n                    <div class=\"ue-item-intro\">El archivo final se organiza para un acceso y una presentaci\u00f3n r\u00e1pidos durante las inspecciones o consultas de la FDA.<\/div>\n                    <\/div>\n\n              <\/div>\n      <\/div>\n<\/div>\n\n  <\/div>\n<\/div>\n<!-- end Horizontal Timeline -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-463a8d8 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"463a8d8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#elementor-action%3Aaction%3Dpopup%3Aopen%26settings%3DeyJpZCI6ODQyNCwidG9nZ2xlIjpmYWxzZX0%3D\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">\u00a1Empieza ya!<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\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<div class=\"elementor-element elementor-element-fc6609c e-flex e-con-boxed e-con e-parent\" data-id=\"fc6609c\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-41e8cb5 e-con-full e-flex e-con e-child\" data-id=\"41e8cb5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a560722 elementor-widget__width-inherit elementor-widget-divider--view-line elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"a560722\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-de23327 elementor-widget__width-initial elementor-widget-tablet__width-inherit elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"de23327\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Servicios relacionados <br><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8ce133e elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"8ce133e\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>La MoCRA exige que todo producto cosm\u00e9tico tenga una prueba documentada de seguridad, disponible para la inspecci\u00f3n de la FDA.<\/p><p><strong>Para que tu cosm\u00e9tica siga cumpliendo todos los requisitos, Sobel te ofrece servicios adicionales de apoyo.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a51b0fe e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"a51b0fe\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-a3ed951 e-con-full e-flex e-con e-child\" data-id=\"a3ed951\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-fd729bf elementor-widget elementor-widget-heading\" data-id=\"fd729bf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">An\u00e1lisis de carencias<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9aace98 elementor-widget elementor-widget-text-editor\" data-id=\"9aace98\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Pre-registration review of cosmetic documents to identify gaps and guide compliance.\"}]\" data-inline-monday=\"true\">Revisi\u00f3n previa al registro de los documentos cosm\u00e9ticos para identificar lagunas y orientar el cumplimiento.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-daf3bb7 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"daf3bb7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/sobelconsult.com\/es\/nuestras-soluciones-cosmeticos-usa-noticias\/mocra-gap-analysis-for-cosmetics-fda-compliance-usa\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Ver m\u00e1s<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-8ec04d9 e-con-full e-flex e-con e-child\" data-id=\"8ec04d9\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-995f279 elementor-widget elementor-widget-heading\" data-id=\"995f279\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Actualizaci\u00f3n del Manual GMP<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-41d6baa elementor-widget elementor-widget-text-editor\" data-id=\"41d6baa\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7d42130 elementor-widget elementor-widget-text-editor\" data-id=\"7d42130\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\"><div class=\"elementor-widget-container\"><div class=\"elementor-element elementor-element-7d42130 elementor-widget elementor-widget-text-editor\" data-id=\"7d42130\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\"><div class=\"elementor-widget-container\"><p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"We help cosmetic manufacturers revise documentation for full compliance.\"}]\" data-inline-monday=\"true\">Ayudamos a los fabricantes de cosm\u00e9ticos a revisar la documentaci\u00f3n para que sea totalmente conforme.<\/p><\/div><\/div><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-99701e8 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"99701e8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/sobelconsult.com\/es\/nuestras-soluciones-cosmeticos-usa-noticias\/cos-us-actualizacion-del-manual-gmp\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Ver m\u00e1s<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-076e69b e-con-full e-flex e-con e-child\" data-id=\"076e69b\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4a68b7a elementor-widget elementor-widget-heading\" data-id=\"4a68b7a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Registro de cosm\u00e9ticos<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9843e1a elementor-widget elementor-widget-text-editor\" data-id=\"9843e1a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"monday-block-1\" contenteditable=\"true\" data-monday-block-type=\"1\" data-monday-block-content=\"[{\"insert\":\"Cosmetic Registration and Product Listing according to the FDA regulamentations.\"}]\" data-inline-monday=\"true\">Registro de cosm\u00e9ticos y listado de productos seg\u00fan la normativa de la FDA.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-365219c elementor-align-center elementor-widget elementor-widget-button\" data-id=\"365219c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/sobelconsult.com\/es\/nuestras-soluciones-cosmeticos-usa-noticias\/cosmetic-registration-support-fda-mocra-compliance-usa\/\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Ver m\u00e1s<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\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>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-f9c4a6e e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"f9c4a6e\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-ee565dd e-con-full e-flex e-con e-child\" data-id=\"ee565dd\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-9e86db1 e-con-full e-flex e-con e-child\" data-id=\"9e86db1\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d7ec254 elementor-widget elementor-widget-heading\" data-id=\"d7ec254\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Construye tu justificaci\u00f3n de seguridad ante la FDA con Sobel<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e582995 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"e582995\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Sobel te ayuda a recopilar y presentar toda la documentaci\u00f3n requerida, creando un expediente listo para la inspecci\u00f3n que demuestre que tus productos son seguros.<\/p><p><strong>As\u00ed que, \u00a1no te arriesgues a retrasos o incumplimientos cuando la FDA solicite tu expediente de seguridad! Habla hoy mismo con nuestro equipo y aseg\u00farate una justificaci\u00f3n de seguridad conforme a la FDA para tus cosm\u00e9ticos. <\/strong><\/p>\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-3830681 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"3830681\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#our-services\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">\u00a1Empieza ya!<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\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\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-40114a1 e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"40114a1\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a584f87 elementor-widget__width-inherit elementor-widget elementor-widget-toggle\" data-id=\"a584f87\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"toggle.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1731\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-1731\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">\u00bfA\u00fan tienes preguntas? Consulta nuestras FAQ <\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1731\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-1731\"><p><strong>1. \u00bfQu\u00e9 es la justificaci\u00f3n de la seguridad seg\u00fan la MoCRA?<\/strong><\/p>\n<p>La justificaci\u00f3n de la seguridad es el requisito de que todo producto cosm\u00e9tico vendido en EE.UU. tenga pruebas documentadas que demuestren que es seguro para el uso al que est\u00e1 destinado. Este expediente puede incluir estudios toxicol\u00f3gicos, revisiones bibliogr\u00e1ficas y an\u00e1lisis de expertos. La FDA puede solicitar su revisi\u00f3n en cualquier momento, por lo que las empresas deben estar preparadas.  <\/p>\n<p><strong>2. \u00bfNecesita cada cosm\u00e9tico un expediente de justificaci\u00f3n de seguridad?<\/strong><\/p>\n<p>S\u00ed. La MoCRA hace obligatoria la documentaci\u00f3n de seguridad para todos los cosm\u00e9ticos comercializados en Estados Unidos, independientemente de que se fabriquen en el pa\u00eds o en el extranjero. Disponer de esta documentaci\u00f3n garantiza que tus productos sigan cumpliendo la normativa y est\u00e9n disponibles para su venta en el mercado estadounidense.  <\/p>\n<p><strong>3. \u00bfQu\u00e9 ocurre si no tengo la documentaci\u00f3n adecuada?<\/strong><\/p>\n<p>Si no puedes proporcionar una justificaci\u00f3n de seguridad adecuada durante una inspecci\u00f3n o investigaci\u00f3n de la FDA, tu empresa puede enfrentarse a cartas de advertencia, retiradas del mercado o detenciones de importaciones. Los expedientes incompletos o desorganizados tambi\u00e9n retrasan la entrada en el mercado y pueden da\u00f1ar tu reputaci\u00f3n ante los organismos reguladores y los socios comerciales. <\/p>\n<p><strong>4. \u00bfPuede Sobel generar nuevos estudios o pruebas de laboratorio?<\/strong><\/p>\n<p>Sobel no realiza pruebas de laboratorio ni estudios cl\u00ednicos. En su lugar, recopilamos, revisamos y organizamos los datos que ya tienes -como informes toxicol\u00f3gicos, estudios publicados y evaluaciones de expertos- en un expediente estructurado de justificaci\u00f3n de seguridad de la FDA.  <\/p>\n<p><strong>5. \u00bfC\u00f3mo aporta Sobel valor a\u00f1adido al proceso?<\/strong><\/p>\n<p>Sobel se asegura de que tus datos de seguridad existentes se presenten de forma que cumplan las expectativas de la FDA y los requisitos de la MoCRA. Nuestros especialistas identifican lagunas, sugieren medidas correctoras y entregan un expediente claro y listo para la inspecci\u00f3n. Esto reduce los riesgos de cumplimiento y permite a tu equipo seguir centrado en la innovaci\u00f3n.  <\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\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>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Sustentaci\u00f3n de la seguridad de los cosm\u00e9ticos Para comercializar en el mercado estadounidense, las empresas cosm\u00e9ticas deben demostrar la seguridad de sus productos con documentaci\u00f3n s\u00f3lida. Sobel te ayuda recopilando datos cient\u00edficos, estudios y an\u00e1lisis en un expediente de justificaci\u00f3n de seguridad conforme a la FDA, alineado con la MoCRA y listo para la inspecci\u00f3n [&hellip;]<\/p>\n","protected":false},"author":15,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-11202","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.3 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Safety Substantiation for Cosmetics | MoCRA Expediente de seguridad del producto<\/title>\n<meta name=\"description\" content=\"Demuestra la seguridad de tu producto cosm\u00e9tico con un expediente completo conforme a la FDA. 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