{"id":3832,"date":"2024-10-01T17:15:21","date_gmt":"2024-10-01T15:15:21","guid":{"rendered":"https:\/\/amsbiopharma.com\/analytical-support\/"},"modified":"2026-09-23T10:29:58","modified_gmt":"2026-09-23T08:29:58","slug":"soporte-analitico","status":"publish","type":"page","link":"https:\/\/amsbiopharma.com\/es\/soporte-analitico\/","title":{"rendered":"Desarrollo de M\u00e9todos Anal\u00edticos\/ GMP"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"3832\" class=\"elementor elementor-3832 elementor-515\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3bbb1079 e-flex e-con-boxed e-con e-parent\" data-id=\"3bbb1079\" 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-386401ae e-con-full e-flex e-con e-child\" data-id=\"386401ae\" 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-36ca91e6 e-con-full e-flex e-con e-child\" data-id=\"36ca91e6\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6e1188b5 elementor-widget elementor-widget-heading\" data-id=\"6e1188b5\" 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\">Desarrollo de M\u00e9todos Anal\u00edticos\/ GMP<\/h2>\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-601091d2 e-con-full e-flex e-con e-child\" data-id=\"601091d2\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7e1177f9 elementor-widget elementor-widget-text-editor\" data-id=\"7e1177f9\" 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>Servicios expertos de desarrollo, validaci\u00f3n y transferencia de m\u00e9todos anal\u00edticos en todas las modalidades terap\u00e9uticas y marcos regulatorios.<\/p>\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<div class=\"elementor-element elementor-element-1d3601d0 e-con-full e-flex e-con e-child\" data-id=\"1d3601d0\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;video&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-3d35c303 e-con-full e-flex e-con e-child\" data-id=\"3d35c303\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;video&quot;,&quot;background_video_link&quot;:&quot;https:\\\/\\\/amsbiopharma.com\\\/wp-content\\\/uploads\\\/Clip4_AnalyticalSupport_SM.mp4&quot;,&quot;background_play_on_mobile&quot;:&quot;yes&quot;,&quot;background_video_start&quot;:0,&quot;background_video_end&quot;:9,&quot;background_play_once&quot;:&quot;yes&quot;}\">\n\t\t<div class=\"elementor-background-video-container\">\n\t\t\t\t\t\t\t<video class=\"elementor-background-video-hosted\" role=\"presentation\" autoplay muted playsinline><\/video>\n\t\t\t\t\t<\/div>\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-3383a05 e-flex e-con-boxed e-con e-parent\" data-id=\"3383a05\" 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-1b6a2b5 e-con-full e-flex e-con e-child\" data-id=\"1b6a2b5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9330bb2 elementor-widget elementor-widget-text-editor\" data-id=\"9330bb2\" 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><span style=\"font-weight: 400;\">Los m\u00e9todos anal\u00edticos son el fundamento t\u00e9cnico del aseguramiento de la <\/span><b>calidad farmac\u00e9utica<\/b><span style=\"font-weight: 400;\"> y el cumplimiento regulatorio. La calidad de un <\/span><b>producto farmac\u00e9utico<\/b><span style=\"font-weight: 400;\"> \u2014y la capacidad de demostrar esa calidad a una autoridad regulatoria\u2014 depende \u00fanicamente de la calidad de los m\u00e9todos anal\u00edticos usados para medirla. El desarrollo de m\u00e9todos robustos, espec\u00edficos, sensibles y reproducibles es una funci\u00f3n cr\u00edtica de calidad y regulatoria.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Para un Responsable de Control de Calidad, el desarrollo y la validaci\u00f3n de m\u00e9todos al est\u00e1ndar regulatorio apropiado \u2014ya sea el <\/span><b>ICH Q2(R2)<\/b><span style=\"font-weight: 400;\"> para m\u00e9todos farmac\u00e9uticos convencionales, el <\/span><b>ICH M10<\/b><span style=\"font-weight: 400;\"> para m\u00e9todos <\/span><b>bioanal\u00edticos<\/b><span style=\"font-weight: 400;\">, o las directrices espec\u00edficas aplicables a biol\u00f3gicos, <\/span><b>oligonucle\u00f3tidos<\/b><span style=\"font-weight: 400;\"> o productos de <\/span><b>terapia g\u00e9nica<\/b><span style=\"font-weight: 400;\">\u2014 es un requisito operativo fundamental.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">AMSbiopharma proporciona servicios integrales de desarrollo, validaci\u00f3n y transferencia de m\u00e9todos anal\u00edticos en toda la gama de t\u00e9cnicas y marcos regulatorios aplicables al desarrollo farmac\u00e9utico, trabajando en colaboraci\u00f3n con los equipos de los patrocinadores.<\/span><\/p>\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-e324efa e-con-full e-flex e-con e-child\" data-id=\"e324efa\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2d627e9 elementor-widget elementor-widget-image\" data-id=\"2d627e9\" 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=\"901\" height=\"365\" src=\"https:\/\/amsbiopharma.com\/wp-content\/uploads\/as.png\" class=\"attachment-large size-large wp-image-3645\" alt=\"\" srcset=\"https:\/\/amsbiopharma.com\/wp-content\/uploads\/as.png 901w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/as-300x122.png 300w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/as-768x311.png 768w\" sizes=\"(max-width: 901px) 100vw, 901px\" \/>\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-3bfdc4e6 e-con-full e-flex e-con e-parent\" data-id=\"3bfdc4e6\" data-element_type=\"container\" data-e-type=\"container\" id=\"discover-menu-container\">\n\t\t<div class=\"elementor-element elementor-element-54ffdca6 e-con-full title-container e-flex e-con e-child\" data-id=\"54ffdca6\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2531214f elementor-widget elementor-widget-heading\" data-id=\"2531214f\" 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\">Descubre<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-30a0468 elementor-widget elementor-widget-html\" data-id=\"30a0468\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8zm144 276c0 6.6-5.4 12-12 12h-92v92c0 6.6-5.4 12-12 12h-56c-6.6 0-12-5.4-12-12v-92h-92c-6.6 0-12-5.4-12-12v-56c0-6.6 5.4-12 12-12h92v-92c0-6.6 5.4-12 12-12h56c6.6 0 12 5.4 12 12v92h92c6.6 0 12 5.4 12 12v56z\"><\/path><\/svg>\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-ab00d17 elementor-nav-menu--dropdown-none discover-menu elementor-widget elementor-widget-nav-menu\" data-id=\"ab00d17\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;layout&quot;:&quot;vertical&quot;,&quot;submenu_icon&quot;:{&quot;value&quot;:&quot;&lt;svg aria-hidden=\\&quot;true\\&quot; class=\\&quot;e-font-icon-svg e-fas-caret-down\\&quot; viewBox=\\&quot;0 0 320 512\\&quot; xmlns=\\&quot;http:\\\/\\\/www.w3.org\\\/2000\\\/svg\\&quot;&gt;&lt;path d=\\&quot;M31.3 192h257.3c17.8 0 26.7 21.5 14.1 34.1L174.1 354.8c-7.8 7.8-20.5 7.8-28.3 0L17.2 226.1C4.6 213.5 13.5 192 31.3 192z\\&quot;&gt;&lt;\\\/path&gt;&lt;\\\/svg&gt;&quot;,&quot;library&quot;:&quot;fa-solid&quot;}}\" data-widget_type=\"nav-menu.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<nav aria-label=\"Men\u00fa\" class=\"elementor-nav-menu--main elementor-nav-menu__container elementor-nav-menu--layout-vertical e--pointer-underline e--animation-fade\">\n\t\t\t\t<ul id=\"menu-1-ab00d17\" class=\"elementor-nav-menu sm-vertical\"><li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4099\"><a href=\"https:\/\/amsbiopharma.com\/es\/impurezas-de-medicamentos\/\" class=\"elementor-item\">Impurezas Regulatorias GMP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4100\"><a href=\"https:\/\/amsbiopharma.com\/es\/soporte-analitico\/\" class=\"elementor-item\">Desarrollo de M\u00e9todos Anal\u00edticos\/ GMP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4101\"><a href=\"https:\/\/amsbiopharma.com\/es\/analisis-de-biofarmaceuticos-basados-en-proteinas\/\" class=\"elementor-item\">An\u00e1lisis de P\u00e9ptidos y Amino\u00e1cidos\/ NO GLP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4102\"><a href=\"https:\/\/amsbiopharma.com\/es\/analisis-de-biofarmaceuticos-basados-en-acidos-nucleicos\/\" class=\"elementor-item\">Oligonucle\u00f3tidos\/ No GLP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4103\"><a href=\"https:\/\/amsbiopharma.com\/es\/analisis-icp-ms\/\" class=\"elementor-item\">An\u00e1lisis ICP-MS<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4104\"><a href=\"https:\/\/amsbiopharma.com\/es\/control-de-calidad-y-estabilidades\/\" class=\"elementor-item\">Control de Calidad (QC Testing)\/ GMP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4105\"><a href=\"https:\/\/amsbiopharma.com\/es\/control-microbiologico\/\" class=\"elementor-item\">Microbiolog\u00eda\/ GMP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4106\"><a href=\"https:\/\/amsbiopharma.com\/es\/cannabis-medicinal\/\" 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P\u00e9ptidos y Amino\u00e1cidos\/ NO GLP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4102\"><a href=\"https:\/\/amsbiopharma.com\/es\/analisis-de-biofarmaceuticos-basados-en-acidos-nucleicos\/\" class=\"elementor-item\" tabindex=\"-1\">Oligonucle\u00f3tidos\/ No GLP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4103\"><a href=\"https:\/\/amsbiopharma.com\/es\/analisis-icp-ms\/\" class=\"elementor-item\" tabindex=\"-1\">An\u00e1lisis ICP-MS<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4104\"><a href=\"https:\/\/amsbiopharma.com\/es\/control-de-calidad-y-estabilidades\/\" class=\"elementor-item\" tabindex=\"-1\">Control de Calidad (QC Testing)\/ GMP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4105\"><a href=\"https:\/\/amsbiopharma.com\/es\/control-microbiologico\/\" class=\"elementor-item\" tabindex=\"-1\">Microbiolog\u00eda\/ GMP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4106\"><a href=\"https:\/\/amsbiopharma.com\/es\/cannabis-medicinal\/\" class=\"elementor-item\" tabindex=\"-1\">Cannabis medicinal<\/a><\/li>\n<\/ul>\t\t\t<\/nav>\n\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-29f518e e-con-full e-flex e-con e-parent\" data-id=\"29f518e\" 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-ede5a45 e-con-full e-flex e-con e-child\" data-id=\"ede5a45\" 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-336e86d elementor-widget elementor-widget-heading\" data-id=\"336e86d\" 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\">Nuestro cat\u00e1logo de servicios incluye<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6b6ddfa e-con-full e-grid e-con e-child\" data-id=\"6b6ddfa\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a20dad8 elementor-widget elementor-widget-image\" data-id=\"a20dad8\" 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=\"2156\" height=\"1641\" src=\"https:\/\/amsbiopharma.com\/wp-content\/uploads\/AM_2026_04_01_BLOG-1.webp\" class=\"attachment-full size-full wp-image-6147\" alt=\"Aplicaciones de Metabol\u00f3mica\" srcset=\"https:\/\/amsbiopharma.com\/wp-content\/uploads\/AM_2026_04_01_BLOG-1.webp 2156w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/AM_2026_04_01_BLOG-1-300x228.webp 300w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/AM_2026_04_01_BLOG-1-1024x779.webp 1024w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/AM_2026_04_01_BLOG-1-768x585.webp 768w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/AM_2026_04_01_BLOG-1-1536x1169.webp 1536w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/AM_2026_04_01_BLOG-1-2048x1559.webp 2048w\" sizes=\"(max-width: 2156px) 100vw, 2156px\" \/>\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-89947aa elementor-widget elementor-widget-n-accordion\" data-id=\"89947aa\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;expanded&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1440\" class=\"e-n-accordion-item\" open>\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"true\" aria-controls=\"e-n-accordion-item-1440\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Desarrollo, Validaci\u00f3n y Transferencia de M\u00e9todos Anal\u00edticos <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-down\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M504 256c0 137-111 248-248 248S8 393 8 256 119 8 256 8s248 111 248 248zM212 140v116h-70.9c-10.7 0-16.1 13-8.5 20.5l114.9 114.3c4.7 4.7 12.2 4.7 16.9 0l114.9-114.3c7.6-7.6 2.2-20.5-8.5-20.5H300V140c0-6.6-5.4-12-12-12h-64c-6.6 0-12 5.4-12 12z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-right\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zM140 300h116v70.9c0 10.7 13 16.1 20.5 8.5l114.3-114.9c4.7-4.7 4.7-12.2 0-16.9l-114.3-115c-7.6-7.6-20.5-2.2-20.5 8.5V212H140c-6.6 0-12 5.4-12 12v64c0 6.6 5.4 12 12 12z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1440\" class=\"elementor-element elementor-element-2001dcf e-con-full e-flex e-con e-child\" data-id=\"2001dcf\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1440\" class=\"elementor-element elementor-element-02796f8 e-flex e-con-boxed e-con e-child\" data-id=\"02796f8\" 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-623a24c elementor-widget elementor-widget-text-editor\" data-id=\"623a24c\" 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><span style=\"font-weight: 400;\">Nuestros servicios de desarrollo de m\u00e9todos comienzan con una comprensi\u00f3n profunda del reto anal\u00edtico: las propiedades fisicoqu\u00edmicas del analito, la complejidad de la matriz, el contexto regulatorio y los requisitos de rendimiento. A partir de esta base, dise\u00f1amos m\u00e9todos anal\u00edticos optimizados para sensibilidad, especificidad, precisi\u00f3n y robustez.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">La <\/span><b>validaci\u00f3n de m\u00e9todos<\/b><span style=\"font-weight: 400;\"> se realiza conforme a las directrices regulatorias aplicables \u2014<\/span><b>ICH Q2(R2)<\/b><span style=\"font-weight: 400;\"> para m\u00e9todos farmac\u00e9uticos cuantitativos, <\/span><b>ICH M10<\/b><span style=\"font-weight: 400;\"> para m\u00e9todos <\/span><b>bioanal\u00edticos<\/b><span style=\"font-weight: 400;\"> regulados\u2014 cubriendo todos los par\u00e1metros de validaci\u00f3n requeridos: especificidad, linealidad, rango, exactitud, precisi\u00f3n, l\u00edmites de detecci\u00f3n y cuantificaci\u00f3n, robustez y estabilidad. Los informes de validaci\u00f3n completos se preparan en formato listo para regulaci\u00f3n.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Los servicios de transferencia de m\u00e9todos garantizan que los m\u00e9todos validados funcionan de manera consistente en los laboratorios receptores, con un ejercicio de comparabilidad interlaboratorio que demuestra un rendimiento equivalente. La documentaci\u00f3n de transferencia cumple los requisitos regulatorios aplicables.<\/span><\/p>\n<p><b>Capacidades anal\u00edticas clave:<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Desarrollo de m\u00e9todos para <\/span><b>HPLC<\/b><span style=\"font-weight: 400;\">, <\/span><b>UHPLC<\/b><span style=\"font-weight: 400;\">, <\/span><b>GC<\/b><span style=\"font-weight: 400;\">, <\/span><b>LC-MS\/MS<\/b><span style=\"font-weight: 400;\">, <\/span><b>HRMS<\/b><span style=\"font-weight: 400;\"> y otras plataformas<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Validaci\u00f3n completa conforme al <\/span><b>ICH Q2(R2)<\/b><span style=\"font-weight: 400;\">, <\/span><b>ICH M10<\/b><span style=\"font-weight: 400;\"> y directrices espec\u00edficas aplicables<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Validaci\u00f3n para mol\u00e9culas peque\u00f1as, p\u00e9ptidos, biol\u00f3gicos y <\/span><b>oligonucle\u00f3tidos<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Transferencia de m\u00e9todos con comparabilidad interlaboratorio y documentaci\u00f3n regulatoria<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Estrategias de validaci\u00f3n adaptadas a la fase para el desarrollo temprano y tard\u00edo<\/span><\/li>\n<\/ul>\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\t\t<\/div>\n\t\t\t\t\t<\/details>\n\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<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<div class=\"entry-summary\">\nDesarrollo de M\u00e9todos Anal\u00edticos\/ GMP Servicios expertos de desarrollo, validaci\u00f3n y transferencia de m\u00e9todos anal\u00edticos en todas las modalidades terap\u00e9uticas y marcos regulatorios. Los m\u00e9todos anal\u00edticos son el fundamento t\u00e9cnico del aseguramiento de la calidad farmac\u00e9utica y el cumplimiento regulatorio.&hellip;\n<\/div>\n<div class=\"link-more\"><a href=\"https:\/\/amsbiopharma.com\/es\/soporte-analitico\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &ldquo;Desarrollo de M\u00e9todos Anal\u00edticos\/ GMP&rdquo;<\/span>&hellip;<\/a><\/div>\n","protected":false},"author":1,"featured_media":4763,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-3832","page","type-page","status-publish","has-post-thumbnail","hentry","entry"],"_links":{"self":[{"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/pages\/3832","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/comments?post=3832"}],"version-history":[{"count":22,"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/pages\/3832\/revisions"}],"predecessor-version":[{"id":6660,"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/pages\/3832\/revisions\/6660"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/media\/4763"}],"wp:attachment":[{"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/media?parent=3832"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}