{"id":7899,"date":"2017-03-27T20:19:41","date_gmt":"2017-03-28T00:19:41","guid":{"rendered":"https:\/\/tunnellconsulting.com\/?page_id=7899"},"modified":"2019-08-08T14:36:23","modified_gmt":"2019-08-08T18:36:23","slug":"regulatory-consulting","status":"publish","type":"page","link":"https:\/\/tunnellconsulting.com\/regulatory-consulting\/","title":{"rendered":"Regulatory Consulting"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"7899\" class=\"elementor elementor-7899\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-dd03ff4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"dd03ff4\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4081524\" data-id=\"4081524\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5c3eaa4 elementor-widget elementor-widget-image\" data-id=\"5c3eaa4\" data-element_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<img fetchpriority=\"high\" decoding=\"async\" width=\"836\" height=\"244\" src=\"https:\/\/tunnellconsulting.com\/wp-content\/uploads\/2017\/03\/2_2-regulatory_3.jpg\" class=\"attachment-large size-large wp-image-7900\" alt=\"\" srcset=\"https:\/\/tunnellconsulting.com\/wp-content\/uploads\/2017\/03\/2_2-regulatory_3.jpg 836w, https:\/\/tunnellconsulting.com\/wp-content\/uploads\/2017\/03\/2_2-regulatory_3-300x88.jpg 300w, https:\/\/tunnellconsulting.com\/wp-content\/uploads\/2017\/03\/2_2-regulatory_3-768x224.jpg 768w\" sizes=\"(max-width: 836px) 100vw, 836px\" \/>\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-cc3f5dc elementor-widget elementor-widget-heading\" data-id=\"cc3f5dc\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Regulatory Consulting<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1590375 elementor-widget elementor-widget-text-editor\" data-id=\"1590375\" data-element_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<h3>TUNNELL HELPS YOU NAVIGATE THE REGULATORY LANDSCAPE THROUGHOUT THE PRODUCT LIFE CYCLE.<\/h3><p>With increasing regulatory pressures it is critical that every phase of your process is scrutinized. That\u2019s what we do. Our consultants bring years of industry experience \u2013 we have walked in your shoes and we understand your regulatory challenges. We see the big picture, from application strategy through product approval and beyond.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b2810db elementor-widget elementor-widget-text-editor\" data-id=\"b2810db\" data-element_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<h3>RELY ON TUNNELL TO GUIDE YOU THROUGH THE PROCESS TO PROMOTE REGULATORY SUCCESS.<\/h3><p>Tunnell provides the guidance, expertise and support for the preparation, accurate submission and maintenance of your regulatory filings to help you get your medicine to patients faster.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ff2bdd4 elementor-widget elementor-widget-text-editor\" data-id=\"ff2bdd4\" data-element_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<ul><li><b>Regulatory Submission<\/b> support including CMC authoring and publishing, PAI readiness assessment, post marketing CMC management including supplements, changes being effected and annual reports.<\/li><li><b>Regulatory Strategy<\/b> consulting including CMC strategy, filing strategy, comparability protocols, specification development and preparation for and participation in agency meetings.<\/li><li><b>Product Development<\/b> guidance including application and review of Quality-by-Design (QbD), question-based development and continued process verification<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9b547c0 elementor-widget elementor-widget-text-editor\" data-id=\"9b547c0\" data-element_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<h3>SUSTAINABLE RESULTS.<\/h3><p>Our seasoned and highly credentialed consultants, who possess years of life sciences industry experience (and many of whom have prior regulatory agency experience) provide guidance regarding interpretation of regulatory requirements and industry guidelines. We share industry best practices to help you develop an effective and efficient resolutions strategy to ensure high quality regulatory submissions.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-a566a33 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"a566a33\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-a130a02\" data-id=\"a130a02\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-cdbb100 elementor-widget elementor-widget-heading\" data-id=\"cdbb100\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Latest Insights<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-75ae4ab elementor-grid-1 elementor-posts--thumbnail-top elementor-grid-tablet-2 elementor-grid-mobile-1 elementor-widget elementor-widget-posts\" data-id=\"75ae4ab\" data-element_type=\"widget\" data-settings=\"{&quot;custom_columns&quot;:&quot;1&quot;,&quot;custom_columns_tablet&quot;:&quot;2&quot;,&quot;custom_columns_mobile&quot;:&quot;1&quot;,&quot;custom_row_gap&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:35,&quot;sizes&quot;:[]},&quot;custom_row_gap_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;custom_row_gap_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"posts.custom\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t      <div class=\"ecs-posts elementor-posts-container elementor-posts   elementor-grid elementor-posts--skin-custom\" data-settings=\"{&quot;current_page&quot;:1,&quot;max_num_pages&quot;:1,&quot;load_method&quot;:&quot;&quot;,&quot;widget_id&quot;:&quot;75ae4ab&quot;,&quot;post_id&quot;:7899,&quot;theme_id&quot;:7899,&quot;change_url&quot;:false,&quot;reinit_js&quot;:false}\">\n      \t\t<article id=\"post-9149\" class=\"elementor-post elementor-grid-item ecs-post-loop post-9149 post type-post status-publish format-standard hentry category-published-articles tag-regulatory\">\n\t\t\t\t<div data-elementor-type=\"loop\" data-elementor-id=\"9058\" class=\"elementor elementor-9058 post-9149 post type-post status-publish format-standard hentry category-published-articles tag-regulatory ast-article-single\" data-elementor-post-type=\"elementor_library\">\n\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-96982a8 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"96982a8\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-a006cba\" data-id=\"a006cba\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-b16b1b4 elementor-widget elementor-widget-heading\" data-id=\"b16b1b4\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-medium\"><a href=\"https:\/\/tunnellconsulting.com\/why-you-should-engage-with-regulatory-early-in-product-development\/\">Why You Should Engage With Regulatory Early in Product Development<\/a><\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f507302 dc-has-condition dc-condition-contains elementor-widget elementor-widget-post-info\" data-id=\"f507302\" data-element_type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<ul class=\"elementor-inline-items elementor-icon-list-items elementor-post-info\">\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-b95e191 elementor-inline-item\" itemprop=\"datePublished\">\n\t\t\t\t\t\t<a href=\"https:\/\/tunnellconsulting.com\/2018\/02\/07\/\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<i class=\"fa fa-calendar\" aria-hidden=\"true\"><\/i>\n\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date\">\n\t\t\t\t\t\t\t\t\t\t<time>February 7, 2018<\/time>\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3c6c0d0 elementor-widget elementor-widget-text-editor\" data-id=\"3c6c0d0\" data-element_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\tTunnell Principal, Kati Abraham, explains the importance of early regulatory engagement.\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ec916ed dc-has-condition dc-condition-empty elementor-widget elementor-widget-button\" data-id=\"ec916ed\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/tunnellconsulting.com\/wp-content\/uploads\/2018\/03\/Why-You-Should-Engage-With-Regulatory-Early-In-Product-Development-1.pdf\" 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 elementor-align-icon-right\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-caret-right\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t<span class=\"elementor-button-text\">READ MORE <\/span>\n\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<!-- hidden widget -->\t\t<div class=\"elementor-element elementor-element-976f2ea elementor-widget elementor-widget-text-editor\" data-id=\"976f2ea\" data-element_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\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t\t\t<\/article>\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<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Regulatory Consulting TUNNELL HELPS YOU NAVIGATE THE REGULATORY LANDSCAPE THROUGHOUT THE PRODUCT LIFE CYCLE. With increasing regulatory pressures it is critical that every phase of<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"page-builder","ast-site-content-layout":"","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"footnotes":""},"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Regulatory Consulting - Tunnell Consulting<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/tunnellconsulting.com\/regulatory-consulting\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Regulatory Consulting - Tunnell Consulting\" \/>\n<meta property=\"og:description\" content=\"Regulatory Consulting TUNNELL HELPS YOU NAVIGATE THE REGULATORY LANDSCAPE THROUGHOUT THE PRODUCT LIFE CYCLE. 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