{"id":8338,"date":"2025-06-05T11:27:54","date_gmt":"2025-06-05T03:27:54","guid":{"rendered":"https:\/\/regask.com\/?p=8338"},"modified":"2025-07-17T10:53:50","modified_gmt":"2025-07-17T02:53:50","slug":"irrumpir-en-los-reclamos-que-cumplen-con-los-estandares-de-ee-uu-para-una-formula-infantil-innovadora","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/breaking-into-the-us-compliant-claims-for-an-innovative-infant-formula\/","title":{"rendered":"Entrar en EE. UU.: Requisitos para una empresa innovadora\u2026"},"content":{"rendered":"<h4><strong>El desaf\u00edo<\/strong><\/h4>\n<p>Introducir una f\u00f3rmula infantil en el mercado estadounidense no se trata solo de innovaci\u00f3n. Se trata de sortear uno de los marcos regulatorios m\u00e1s rigurosos del mundo. Un fabricante global hab\u00eda desarrollado una f\u00f3rmula novedosa con un ingrediente \u00fanico, pero necesitaba asegurarse de que las afirmaciones de su producto se mantuvieran bajo el escrutinio de la FDA estadounidense. Ah\u00ed es donde intervino RegASK.<\/p>\n<h4><strong>La Misi\u00f3n<\/strong><\/h4>\n<p>Aseg\u00farese de que las declaraciones de estructura\/funci\u00f3n (S\/F) del producto cumplan con los est\u00e1ndares de la FDA de EE. UU. sin perder la integridad cient\u00edfica ni la ventaja competitiva de la f\u00f3rmula.<\/p>\n<h4 data-start=\"575\" data-end=\"844\"><strong data-start=\"575\" data-end=\"598\">El enfoque RegASK<\/strong><\/h4>\n<p><span data-teams=\"true\">RegASK combin\u00f3 su <a href=\"https:\/\/regask.com\/es\/producto\/#RegGenius:~:text=Book%20a%20demo-,RegGenius,-Your%20GenAI%20co\">Plataforma impulsada por IA<\/a> con profunda experiencia en el dominio para liderar una revisi\u00f3n espec\u00edfica, garantizando velocidad, precisi\u00f3n y alineaci\u00f3n regulatoria<\/span>:<\/p>\n<ul>\n<li>Realizamos una revisi\u00f3n bibliogr\u00e1fica exhaustiva, centr\u00e1ndonos exclusivamente en datos relevantes para la poblaci\u00f3n infantil estadounidense.<\/li>\n<li>Nuestros expertos tradujeron hallazgos cl\u00ednicos complejos en afirmaciones cient\u00edficamente fundamentadas y que cumplen con las normas de la FDA.<\/li>\n<li>Toda la informaci\u00f3n se recopil\u00f3 en un expediente de justificaci\u00f3n de la reclamaci\u00f3n, dise\u00f1ado para su examen, aprobaci\u00f3n y \u00e9xito.<\/li>\n<\/ul>\n\t<div id=\"gap-910475930\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-910475930 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><strong>Aspectos destacados clave<\/strong><\/h4>\n\t<div id=\"gap-2027223661\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2027223661 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n\t<div id=\"stack-527707442\" class=\"stack stack-row justify-start items-stretch\">\n\t\t\n<div class=\"row equal-height-row\"  id=\"row-1038837952\">\n\n\t<div id=\"col-617614981\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner text-left dark\" style=\"background-color:rgb(10, 35, 66);\" >\n\t\t\t\n\t\t\t\n<h1>45<\/h1>\n<p>publicaciones cient\u00edficas revisadas en &lt;1 mes<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-617614981 > .col-inner {\n  padding: 10% 10% 10% 10%;\n  border-radius: 16px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-18079405\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner\" style=\"background-color:#e5e8fb;\" >\n\t\t\t\n\t\t\t\n<h1>10<\/h1>\n<p>Afirmaciones identificadas en torno a la cognici\u00f3n, la salud digestiva, los prebi\u00f3ticos\/inmunidad<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-18079405 > .col-inner {\n  padding: 10% 10% 10% 10%;\n  border-radius: 16px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-93700\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner dark\" style=\"background-color:#0a2342;\" >\n\t\t\t\n\t\t\t\n<h1>2<\/h1>\n<p>Producto lanzado con \u00e9xito<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-93700 > .col-inner {\n  padding: 10% 10% 10% 10%;\n  border-radius: 16px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n<style>\n#row-1038837952 > .col > .col-inner {\n  background-color: #0a2342;\n  border-radius: 14px;\n}\n<\/style>\n<\/div>\n\t\t\n<style>\n#stack-527707442 > * {\n  --stack-gap: 0rem;\n}\n<\/style>\n\t<\/div>\n\t\n\t<div id=\"gap-1052053986\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1052053986 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n<a href=\"https:\/\/regask.com\/es\/contacto\/\" class=\"button primary\" >\n\t\t<span>Conozca m\u00e1s sobre el enfoque RegASK con nuestro Equipo<\/span>\n\t<\/a>\n\n\t<div id=\"gap-80740918\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-80740918 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4 data-start=\"1058\" data-end=\"1252\"><strong data-start=\"1058\" data-end=\"1072\">El resultado<\/strong><\/h4>\n<p data-start=\"1058\" data-end=\"1252\">Con la inteligencia regulatoria proactiva y la validaci\u00f3n de reclamos de RegASK, el cliente se lanz\u00f3 con \u00e9xito al mercado estadounidense, a tiempo y con confianza. <span data-teams=\"true\">Respaldada por afirmaciones fundamentadas y conformes, su f\u00f3rmula innovadora cumpli\u00f3 con el escrutinio de la FDA e ingres\u00f3 con \u00e9xito al mercado estadounidense.<\/span><\/p>\n<p><strong>No se trataba solo de cumplir con las normativas. Se trataba de liberar el potencial del mercado, de forma m\u00e1s r\u00e1pida e inteligente, con el RegASK a su lado.<\/strong><\/p>\n<div class=\"is-divider divider clearfix\" style=\"max-width:100%;height:2px;background-color:rgb(197, 202, 236);\"><\/div>\n\t<div id=\"gap-2107892418\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2107892418 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>Preguntas frecuentes<\/h2>\n\t<div id=\"gap-139771338\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-139771338 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><strong>P1: \u00bfC\u00f3mo puede RegASK ayudar a las empresas a ingresar al mercado estadounidense de f\u00f3rmulas infantiles?<\/strong><strong>?<\/strong><\/h4>\n<p>RegASK apoya a las empresas que ingresan al mercado de f\u00f3rmulas infantiles de EE. UU. brind\u00e1ndoles orientaci\u00f3n experta sobre las regulaciones de la FDA, el etiquetado, los requisitos de seguridad y las v\u00edas de registro.<\/p>\n<p>Realizamos revisiones de cumplimiento de f\u00f3rmulas y etiquetas, evaluaciones de ingredientes, verificaciones de formulaci\u00f3n y evaluaciones tanto cuantitativas como cualitativas. Esto ayuda a garantizar el cumplimiento, agilizando la aprobaci\u00f3n y la entrada al mercado.<\/p>\n<h4><strong>P2: \u00bfQu\u00e9 hace que RegASK sea diferente de los consultores regulatorios tradicionales?<\/strong><\/h4>\n<p>RegASK combina tecnolog\u00eda avanzada con una profunda experiencia regulatoria. Su comunidad global de expertos en la materia y su enfoque pr\u00e1ctico y orientado al negocio ofrecen informaci\u00f3n m\u00e1s r\u00e1pida y pr\u00e1ctica para el cumplimiento normativo de los productos y su entrada al mercado. Puede aprovechar la red global de pymes locales de RegASK y tener un \u00fanico punto de contacto con los expertos de RegASK para garantizar la calidad de los resultados.<\/p>\n<h4><\/h4>\n<h4><\/h4>\n<h4><strong>P3: \u00bfPuede RegASK respaldar el lanzamiento de productos en categor\u00edas altamente reguladas como la nutrici\u00f3n infantil?<\/strong><\/h4>\n<p>Por supuesto. RegASK cuenta con una s\u00f3lida trayectoria en los sectores de las ciencias de la vida y la nutrici\u00f3n, incluyendo f\u00f3rmulas infantiles, alimentos para usos m\u00e9dicos especiales (FSMP), alimentos fortificados y suplementos diet\u00e9ticos. Nuestra experiencia va m\u00e1s all\u00e1 del conocimiento regulatorio; comprendemos los principios cient\u00edficos que sustentan la formulaci\u00f3n, la seguridad y la eficacia nutricional de los productos.<\/p>\n<p>Esto nos permite ofrecer una orientaci\u00f3n precisa y basada en la evidencia, adaptada a categor\u00edas complejas y altamente reguladas. Junto con nuestra experiencia pr\u00e1ctica en aplicaciones regulatorias, facilitamos el acceso al mercado y el cumplimiento normativo.<\/p>\n<h4><\/h4>\n<h4><\/h4>\n<h4><strong>P4: \u00bfQu\u00e9 sucede si los est\u00e1ndares regulatorios cambian a mitad de la planificaci\u00f3n del lanzamiento?<\/strong><\/h4>\n<p><span data-teams=\"true\">Ah\u00ed es donde entra en juego RegAlerts. RegASK monitorea continuamente los cambios regulatorios relevantes y actualiza a su equipo con informaci\u00f3n seleccionada, para que su estrategia se mantenga alineada con los \u00faltimos est\u00e1ndares.<\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>The Challenge Bringing an infant formula to the U.S. market isn\u2019t just about innovation. It\u2019s about navigating one of the most rigorous regulatory landscapes in the world. A global manufacturer had developed a novel formula with a unique ingredient but needed to make sure their product claims would hold up under U.S. FDA scrutiny. That\u2019s&#8230;<\/p>","protected":false},"author":43,"featured_media":8343,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[17,527,18],"tags":[197],"class_list":["post-8338","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-case-study","category-united-states-regulations","category-food-and-beverage","tag-infant-formula"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.6 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>US | Innovative Infant Formula | Case Study | RegASK<\/title>\n<meta name=\"description\" content=\"How RegASK enabled FDA-compliant claims for a successful US launch of an innovative infant formula.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link 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