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Cell Therapy Regulatory Guidance - OmniaBio
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.e-con.e-parent:nth-of-type(n+2):not(.e-lazyloaded):not(.e-no-lazyload) * { background-image: none !important; } } </style> <link rel="icon" href="https://omniabio.com/wp-content/uploads/2023/10/favicon_48x48.png" sizes="32x32" /> <link rel="icon" href="https://omniabio.com/wp-content/uploads/2023/10/favicon_48x48.png" sizes="192x192" /> <link rel="apple-touch-icon" href="https://omniabio.com/wp-content/uploads/2023/10/favicon_48x48.png" /> <meta name="msapplication-TileImage" content="https://omniabio.com/wp-content/uploads/2023/10/favicon_48x48.png" /> <style id="wp-custom-css"> /****__ General __****/ a { color: unset; } .btnPrimary .elementor-button { color: #fff; } .darkBg a { color: #fff; } /****__ Header __****/ .site-primary-header-wrap { padding: 0 10px !important; } .ast-above-header-bar .site-above-header-wrap { height: 12px; min-height: unset !important; } .topbar-shape { position: relative; overflow: unset; height: 6px; width: 205px; margin: 0; background: unset; border: unset; border-top-right-radius: 2px; border-bottom-right-radius: 2px; background: #374581; background: -moz-linear-gradient(left, #374581 0%, #3a7e89 48%, #47908f 81%, #0da480 100%); background: -webkit-linear-gradient(left, #374581 0%,#3a7e89 48%,#47908f 81%,#0da480 100%); background: linear-gradient(to right, #374581 0%,#3a7e89 48%,#47908f 81%,#0da480 100%); filter: progid:DXImageTransform.Microsoft.gradient( startColorstr='#374581', endColorstr='#0da480',GradientType=1 ); } .topbar-shape:before { content: ""; width: 0px; height: 0px; border-style: solid; border-width: 3px 0 3px 5px; border-color: transparent transparent transparent #0DA480; border-radius: 2px; transform: rotate(0deg); position: absolute; right: -4px; top: 0px; } .topbar-shape:after { content: ""; width: 9px; height: 9px; margin-top: -4px; background-color: #0DA480; position: absolute; transform: rotate(45deg); right: -14px; top: 50%; } .site-header-primary-section-right .header-widget-area { position: absolute; top: 0; right: 0; height: auto; display: flex; column-gap: 35px; row-gap: 15px; padding: 25px 0 0; } .site-header-primary-section-right { position: relative; padding-top: 62px; padding-bottom: 38px; transition: all 0.4s ease; } .site-header-primary-section-right .header-widget-area section { margin: 0; display: flex; } .site-header-primary-section-right .header-widget-area section hr { margin: 0 !important; margin-top: 4px !important; } .site-header-primary-section-right .header-widget-area section p { margin: 0; line-height: 1.2; font-family: 'Archivo', sans-serif; font-weight: 500; } .topBar-info a { text-decoration: underline; color: var(--e-global-color-primary); } .ast-desktop .ast-primary-header-bar .main-header-menu > .menu-item { margin-left: 26px; } .main-header-menu .sub-menu .menu-link { background-color: var(--ast-global-color-1); color: #fff; } .main-header-menu .sub-menu .menu-item:hover .menu-link { color: #fff; opacity: 0.8; } .main-header-menu .sub-menu .menu-item.current-menu-item .menu-link { color: rgba(255,255,255,1); } .main-header-menu .sub-menu { padding: 12px 0; background-color: var(--e-global-color-secondary); width: max-content; max-width: unset; min-width: unset; } .main-header-menu .sub-menu .menu-link { padding-top: 9px; padding-bottom: 9px; } .main-header-menu .sub-menu .menu-link:hover { opacity: 0.9; } .header-social-inner-wrap a, .footer-social-inner-wrap a { transition: all 0.4s ease; } /** Sticky **/ #masthead.sticky .site-logo-img img { width: 90%; } .site-header .header-widget-area figure { margin: 0; padding: 0; } #masthead.sticky { background-color: #fff; position: fixed; box-shadow: 0 3px 6px 0 rgb(0 0 0 / 16%); width: 100%; } .site-header.sticky .site-header-primary-section-left .ast-builder-layout-element .site-branding { padding: 0; } .site-header.sticky .site-header-primary-section-right { padding-top: 50px; padding-bottom: 18px; } /** Sticky /**/ @media (max-width: 1024px) { .site-logo-img img { width: 215px; } .ast-desktop .ast-primary-header-bar .main-header-menu > .menu-item { margin-left: 15px; } .ast-builder-menu-1 .menu-item > .menu-link { font-size: 14px; } } @media (max-width: 921px) { .site-primary-header-wrap { padding: 15px !important; } .site-header-primary-section-right .header-widget-area { display: flex !important; } .ast-primary-header-bar .ast-builder-grid-row { grid-template-columns: auto 1fr; } .topbar-shape { width: 120px; } .ast-button-wrap .menu-toggle.main-header-menu-toggle { padding: 4px; } .site-header-primary-section-right { position: static; } .site-header-primary-section-right .header-widget-area { width: 100%; padding: 15px; justify-content: flex-end; } .site-header-primary-section-right .header-widget-area #block-8 { width: 100px; } .site-header-primary-section-right .header-widget-area #block-11 { width: auto; } .topbar-shape { width: 100%; } .site-header-primary-section-right { padding-top: 0; padding-bottom: 0; } .ast-mobile-header-wrap .ast-above-header-bar { min-height: 12px; } .ast-main-header-wrap .site-header-section { padding: 50px 0 0; } .ast-main-header-wrap .site-branding { padding: 0; } #ast-hf-mobile-menu .sub-menu { padding: 0; } .ast-builder-menu-mobile .main-navigation .menu-item:hover .menu-link { color: #fff; } .ast-builder-menu-mobile .main-navigation .menu-item:hover .ast-menu-toggle path { fill: #fff; } } @media (max-width: 767px) { .site-header-primary-section-right .header-widget-area #block-8 { display: none; } .site-header-primary-section-right .header-widget-area #block-11 { text-align: right; } } /****__ Header __/****/ /****__ Footer __****/ .ast-builder-footer-grid-columns { max-width: 1360px !important; grid-column-gap: 15px; } .ast-builder-grid-row-3-cwide .ast-builder-grid-row { grid-template-columns: 250px 3fr 155px; padding: 0 10px; } .menu-footer-menu-container { display: flex; justify-content: flex-end; padding-right: 40px; } .footer-social-inner-wrap:before { content: "Follow Us"; margin-right: 10px; font-family: 'Archivo', sans-serif; font-size: 16px; font-weight: 400; line-height: 16px; color: #fff; } #menu-footer-menu { display: grid; grid-template-columns: repeat(4, auto); grid-column-gap: 75px; grid-row-gap: 15px; } #menu-footer-menu > li { line-height: 1; } #menu-footer-menu .sub-menu { margin-top: 10px; } #menu-footer-menu > li > a { font-weight: 700; pointer-events: none; } #menu-footer-menu li a { font-size: 14px; } .ast-footer-copyright a { color: #fff!important; } .ast-footer-copyright a:hover { color: var(--e-global-color-accent); } #menu-footer-menu a:hover { color: var(--e-global-color-accent); } #menu-footer-menu .sub-menu .menu-item { padding: 0; line-height: 1; } #menu-footer-menu .sub-menu .menu-item:not(:last-child) { margin-bottom: 8px; } #menu-footer-menu li a:not(:hover) { color: #fff; } @media (max-width: 1180px) { .ast-builder-grid-row-3-cwide .ast-builder-grid-row { grid-template-columns: 205px auto 140px; } #menu-footer-menu { grid-column-gap: 40px; } } @media (max-width: 1024px) { .menu-footer-menu-container { padding-right: 10px; } #menu-footer-menu { grid-column-gap: 25px; } } @media (max-width: 980px) { #menu-footer-menu li a { font-size: 13px; } } @media (max-width: 921px) { .ast-builder-grid-row-3-cwide .ast-builder-grid-row { grid-template-columns: 1fr !important; } .menu-footer-menu-container { justify-content: flex-start; } [data-section="section-fb-social-icons-1"] .footer-social-inner-wrap { text-align: left !important; } .site-footer-primary-section-3 .wp-container-1 { justify-content: flex-start !important; } .ast-footer-copyright { text-align: left !important; } .site-primary-footer-wrap[data-section="section-primary-footer-builder"].ast-footer-row-tablet-stack .site-footer-section { margin-bottom: 30px; } .site-primary-footer-wrap[data-section="section-primary-footer-builder"].ast-footer-row-tablet-stack .site-footer-section:last-child { margin-bottom: 0; } .menu-footer-menu-container { padding-right: 0px; } .site-footer-section-2 { margin-bottom: 45px !important; } .site-footer-section-3 .footer-widget-area { margin-bottom: 0; } } @media (max-width: 580px) { #menu-footer-menu { grid-template-columns: repeat(2, auto); grid-column-gap: 75px; } } /****__ Home page __****/ /**__ Banner __**/ @media (min-width: 1301px) { .homeBanner { min-height: calc(100vh - 138px); position: relative; } } .pageBar--fullH { min-height: calc(100vh - 138px); position: relative; } .homeBanner .elementor-background-video-container video { display: block !important; width: 100% !important; height: 100% !important; object-position: right; } .homeBanner__mVid { display: none !important; z-index: -1; width: 100%; height: 100%; } .homeBanner__button .elementor-button { position: relative; } .homeBanner__button .elementor-button span { z-index: 10; } .homeBanner__button .elementor-button:before { content: ""; width: calc(100% + 16px); height: calc(100% + 4px); background-color: var(--e-global-color-accent ); position: absolute; top: -2px; left: -14px; z-index: 0; transform: scaleX(0.062); transform-origin: left; transition: all 0.4s ease; } .homeBanner__button .elementor-button:hover:before { transform: scaleX(1); } @media (max-width: 1300px) { .homeBanner > .homeBanner__cont > .e-con-inner { padding-top: 160px; padding-bottom: 160px; } } @media (max-width: 1200px) { .homeBanner > .homeBanner__cont > .e-con-inner { padding-top: 100px; padding-bottom: 100px; } } @media (max-width: 1100px) { .homeBanner__title .elementor-heading-title { font-size: 60px !important; } .homeBanner__subTitle .elementor-heading-title { font-size: 38px !important; } } @media (max-width: 1024px) { .homeBanner__cont { height: 100%; display: flex; flex-shrink: 0 !important; flex-grow: 1 !important;` } } @media (max-width: 860px) { .homeBanner .homeBanner__cont > .e-con-inner { padding-top: 64px !important; padding-bottom: 76px !important; } } @media (max-width: 820px) { .homeBanner__title .elementor-heading-title { font-size: 50px !important; } .homeBanner__subTitle .elementor-heading-title { font-size: 32px !important; } } @media (max-width: 767px) { .homeBanner__title .elementor-heading-title { font-size: 46px !important; } .homeBanner__subTitle .elementor-heading-title { font-size: 30px !important; } .homeBanner .homeBanner__cont > .e-con-inner > .elementor-background-video-container { display: block !important; } } @media (max-width: 675px) { .homeBanner__title .elementor-heading-title { font-size: 38px !important; } .homeBanner__subTitle .elementor-heading-title { font-size: 24px !important; } } @media (max-width: 600px) { .homeBanner { min-height: calc(100vh - 138px); } .homeBanner .homeBanner__cont > .e-con-inner { padding-top: 40px !important; padding-bottom: 50px !important; } .homeBanner .homeBanner__cont > .e-con-inner > .elementor-background-video-container { display: none !important; } .homeBanner > .homeBanner__cont > .e-con-inner { flex-direction: column-reverse; } .homeBanner__mVid { display: block !important; } .homeBanner__mVid video { object-position: center !important; } } .homeBanner__title span, .pageBar__title span { color: var(--e-global-color-accent); } /****__ Banner __/****/ .oxGrid__boxInner { height: 100%; justify-content: flex-start; } .oxGrid__boxInner .elementor-widget-button { margin-top: auto; } .oxGrid__boxInner > .e-con-inner { justify-content: flex-start !important; } .oxGrid__boxInner > .e-con-inner .elementor-widget-button { margin-top: auto; } .oxGrid__box { flex-direction: column !important; flex-wrap: nowrap !important; } .oExp__gal .gallery-item { padding: 0 !important; max-width: 100% !important; } .oExp__gal .gallery { margin: 0 !important; display: grid; grid-template-columns: repeat( auto-fit, minmax(196px, auto)); align-items: center; grid-column-gap: 30px; grid-row-gap: 30px; } .pageBar__infoTxt p { margin-bottom: 0; } .pageBar__infoShape .elementor-divider-separator:before { content: ""; width: 0px; height: 0px; border-style: solid; border-width: 4px 0 4px 6px; border-color: transparent transparent transparent var(--e-global-color-accent ); border-radius: 2px; position: absolute; right: -4px; top: -7px; } .pageBar__infoShape .elementor-divider-separator:after { content: ""; width: 9px; height: 9px; margin-top: -7px; background-color: var(--e-global-color-accent ); position: absolute; transform: rotate(45deg); right: -15px; top: 50%; } .pageBar__infoShape .elementor-divider-separator { position: relative; } .oList .elementor-icon-list-icon { transform: rotate(45deg); } @media (max-width: 767px) { .oExp .e-con-inner { display: grid; } } .wDefine__grid .e-con-inner { display: grid; grid-template-columns: 1fr 1fr; grid-column-gap: 0; margin-left: 0; } .wDefine__grid .e-con-inner .wDefine__gItem:first-child:before { content: ""; width: 2px; height: 100%; background-color: var(--e-global-color-primary); position: absolute; right: 0; top: 0; } .wDefine__grid .e-con-inner .wDefine__gItem p { width: 450px; max-width: 100%; margin-left: auto; margin-right: auto; } .oxoDemand__grid > .e-con-inner { display: grid; grid-template-columns: repeat( auto-fit, minmax(245px, auto)); } .oxoDemand__fImg { width: 100%; height: 100%; z-index: -1; } .oxoDemand > .e-con-inner > *:not(.oxoDemand__fImg) { position: relative; z-index: 10; } .oxoDemand__fImg img { height: 125%; object-fit: contain; margin-right: -88%; position: relative; margin-top: -50px; } @media (max-width:767px) { .wDefine__grid .e-con-inner { grid-template-columns: 1fr; } } /****__ Career Page __****/ @media (min-width: 768px) { .careerInfo__title .elementor-widget-container { background-image: unset !important; } } @media (max-width: 767px){ .careerInfo .careerInfo__item { max-width: 100%; } } /****__ OmniaBio in the News __****/ .oIconList ul { list-style-type: none; padding: 0; margin: 0; } .oIconList ul li { position: relative; padding-left: 35px; } .oIconList ul li:before { content: "\f45c"; font-family: "Font Awesome 5 Free"; font-weight: 900; font-size: 13px; color: var(--e-global-color-secondary ); margin-right: 18px; position: absolute; left: 0; top: 1px; transform: rotate(45deg); } .oIconList ul li:not(:last-child) { margin-bottom: 20px; } .oEvents__grid > .e-con-inner { display: grid; grid-template-columns: repeat( auto-fit, minmax(313.75px, 1fr)); } /****__ Team Page __****/ .teamGrid .ae-post-collection .ae-post-item { transform: unset; } .teamClick { cursor: pointer; } .teamBox .ue-simple-popup-trigger-wrapper { display: none; } .teamBox__mLink .ue-simple-popup-wrapper { height: auto !important; max-height: 90vh !important; } .teamBox__title .ae-element-post-title { margin-bottom: 0; } .teamDetail__title .ae-element-post-title { margin: 0; } .teamClick .ae_thumb_wrapper { opacity: 1; transition: opacity 0.4s ease; } .teamClick:hover .ae_thumb_wrapper { opacity: 0.8; } .teamBox__mLink .ue-simple-popup-inner { max-width: 100%; } .teamBox__mLink .ue-simple-popup-wrapper { max-width: 100%; } @media (max-width: 640px) { .teamBox__mLink .ue-simple-popup-wrapper { padding: 50px 25px 35px !important; } .teamBox__mLink .ue-simple-popup-close { right: 0 !important; top: 5px !important; } } /****__ Resources __****/ .resBox__tax .ae-term-item { line-height: 1.2; } .resBox__tax.resBox__sArea .ae-custom-tax .ae-term-item:not(:first-child) { /* display: none; */ } .resBox__tax { line-height: 0.5; } .resBox { height: 100%; } .snf ul { padding: 0; margin: 0; display: flex; flex-wrap: wrap; column-gap: 20px; row-gap: 10px; align-items: center; } .snf form > ul:before { content: "Filter by:"; font-weight: 700; } .snf ul li { margin: 0; padding: 0; } .snf ul .search-filter-reset { padding: 10px 30px; background-color: var(--e-global-color-primary ) !important; color: #fff; transition: all 0.4s ease; } .snf ul .search-filter-reset:hover { background-color: #ECA100 !important; } .snf ul li * { font-size: 16px !important; font-family: inherit !important; font-weight: 400 !important; color: #000; } .snf ul li select { height: 40px; padding: 8px 10px; background-color: #fff; border-color: #000; border-radius: 0; } @media (max-width: 767px) { .resGrid .ae-post-item { width: 496px; max-width: 100%; } } @media (max-width: 640px) { .snf ul:before { width: 100%; } } .single-post .ast-container { padding: 0; } .newsDet__cont h1, .newsDet__cont h2, .newsDet__cont h3, .newsDet__cont h4, .newsDet__cont h5, .newsDet__cont h6 { margin-bottom: 5px; margin-top: 25px; } .newsDet__cont a:hover { color: var(--e-global-color-accent ); } .nbcShape { position: absolute; top: -150px; right: -125px; line-height: 1; font-size: 0; } .nbcShape .ae-element-post-category span { width: 200px; height: 200px; background-color: var(--e-global-color-accent ); font-size: 0; border-radius: 100%; line-height: 0; } .nbcShape * { font-size: 0; line-height: 1; } .fNewsBlock, .newsBlock { overflow: hidden; } .nbcShape .ae-element-post-category .ae-category-news { background-color: var(--e-global-color-accent ); } .fNewsBlock__title .ae-element-post-title, .newsBlock__title .ae-element-post-title { margin-bottom: 0 !important; } .fNewsBlock__title a, .newsBlock__title a { text-decoration: unset !important; } .fNewsBlock__cat a, .newsBlock__cat a { text-decoration: unset !important; } .newsBlock { height: 100%; } .snf--news .sf-field-category li { min-width: 99px; text-align: center; padding: 4px 15px; background-color: transparent; position: relative; overflow: hidden; border: 2px solid var(--e-global-color-primary); cursor: pointer; } .snf--news .sf-field-category li label { font-weight: bold !important; margin: 0; padding: 0; line-height: 1; color: var(--e-global-color-primary); } .snf--news .sf-field-category li:hover, .snf--news .sf-field-category li.sf-option-active { background-color: var(--e-global-color-primary); } .snf--news .sf-field-category li .sf-input-radio { position: absolute; width: 100%; height: 100%; top: 0; left: 0; z-index: 0; opacity: 0; cursor: pointer; } .snf--news .sf-field-category li { transition: all 0.4s ease; } .snf--news .sf-field-category li.sf-item-6 { background: transparent; border-color: #393F79; } .snf--news .sf-field-category li.sf-item-6 label { color: #393F79; } .snf--news .sf-field-category li.sf-item-6:hover, .snf--news .sf-field-category li.sf-item-6.sf-option-active { background: #393F79; } .snf--news .sf-field-category li.sf-item-1 { background: transparent; border-color: var(--e-global-color-secondary); } .snf--news .sf-field-category li.sf-item-1 label { color: var(--e-global-color-secondary); } .snf--news .sf-field-category li.sf-item-1:hover, .snf--news .sf-field-category li.sf-item-1.sf-option-active { background: var(--e-global-color-secondary); } .snf--news .sf-field-category li.sf-item-7 { background: transparent; border-color: var(--e-global-color-d969f71); } .snf--news .sf-field-category li.sf-item-7 label { color: var(--e-global-color-d969f71); } .snf--news .sf-field-category li.sf-item-7:hover, .snf--news .sf-field-category li.sf-item-7.sf-option-active { background: var(--e-global-color-d969f71); } .snf--news .sf-field-category li:hover label, .snf--news .sf-field-category li.sf-option-active label { color: #fff; } .newsBlock__cat .ae-category-news, .fNewsBlock__cat .ae-category-news{ color: #393F79 !important; } .newsBlock__cat .ae-category-press-releases, .fNewsBlock__cat .ae-category-press-releases { color: var(--e-global-color-secondary) !important; } .newsBlock__cat .ae-category-recent-highlights, .fNewsBlock__cat .ae-category-recent-highlights{ color: var(--e-global-color-d969f71) !important; } .newsDet__cat .ae-category-news { border-color: #393F79 !important; color: #393F79 !important; } .newsDet__cat .ae-category-press-releases { border-color: var(--e-global-color-secondary) !important; color: var(--e-global-color-secondary) !important; } .newsDet__cat .ae-category-recent-highlights { border-color: var(--e-global-color-d969f71) !important; color: var(--e-global-color-d969f71) !important; } .nbcShape .ae-category-news { background-color: #393F79 !important; } .nbcShape .ae-category-press-releases { background-color: var(--e-global-color-secondary) !important; } .nbcShape .ae-category-recent-highlights { background-color: var(--e-global-color-d96f71) !important; } .resGrid .ae-post-collection .search-filter-scroll-loading, .newsPosts__grid .ae-post-collection .search-filter-scroll-loading { animation: unset; border: unset; margin: 0; padding: 0; height: auto; width: auto; display: flex; justify-content: center; grid-column: 1 / -1; } .resGrid .ae-post-collection .search-filter-scroll-loading:before, .newsPosts__grid .ae-post-collection .search-filter-scroll-loading:before{ content: ""; display: inline-block; margin: 0; height: 50px; width: 50px; animation: search-filter-loader-rotate .7s infinite linear; border: 8px solid rgba(0,0,0,.15); border-right-color: rgba(0,0,0,.6); border-radius: 50%; } @media (max-width: 767px) { .oeodSec__fImg { top: unset !important; bottom: 0; } } /****__ Hubspot Form __****/ .hsForm fieldset { max-width: 100% !important; margin-bottom: 20px !important; } .hsForm .form-columns-2 { display: grid !important; grid-template-columns: 1fr 1fr; grid-column-gap: 20px; grid-row-gap: 20px; } .hsForm .form-columns-2 .hs-form-field { width: unset !important; float: unset !important; } .hsForm .hs-form-field { margin-bottom: 20px; } .hsForm fieldset .hs-form-field { margin-bottom: 0; } .hsForm .hs-form-field .input { margin: 5px 0 0 !important; } .hsForm .hs-form-field .input input { height: 55px; } .hsForm .hs-form-field .input .hs-input:not([type="radio"]):not([type="checkbox"]) { width: 100% !important; padding: 10px; background: #fff; border: 1px solid #bababa; } .hsForm .hs-form-field label:not(.hs-error-msg) { font-weight: 700; font-size: 18px; } .hsForm .hs-form-field .hs-field-desc { font-size: 15px; line-height: 15px; margin: 0; padding: 0; color: #343434; } .hsForm .hs-error-msgs { list-style-type: none !important; padding: 0; margin: 0; font-size: 14px; color: red; } .hsForm .hs-form-field textarea { width: 100% !important; background: #fff; } .hsForm .hs-richtext { font-size: 18px; } .hsForm .legal-consent-container .hs-form-field .input { margin: 0 !important; } .hsForm .legal-consent-container .hs-form-field .input .inputs-list, .hsForm .hs-fieldtype-radio .inputs-list { list-style-type: none; padding: 0; } .hsForm .hs-fieldtype-booleancheckbox input.hs-input, .hsForm .hs-fieldtype-radio input.hs-input { width: unset !important; padding: unset !important; height: unset !important; margin-top: 5px; margin-right: 12px; } .hsForm .hs-fieldtype-radio .inputs-list label { font-weight: 500 !important; font-size: 15px !important; } .hsForm .hs-input { font-size: 15px; } .hsForm .hs_submit { margin-top: 45px; } .hsForm .hs_submit .hs-button { transition: all 0.4s ease; } .hsForm .hs-input { border-style: solid !important; } .hsForm .hs-input:focus { border-color: var(--e-global-color-primary) !important; } .hsForm .hs_error_rollup { margin-top: 30px; } @media (max-width: 767px) { .hsForm .form-columns-2 { grid-template-columns: 1fr; } } .cky-notice-btn-wrapper .cky-btn { font-size: 14px !important; line-height: 16px; padding: 10px 22px; } /*** Events item ***/ .oEvents__item{ max-height:360px; } @media (max-width:768px){ .oEvents__item{ max-height:400px; } } /*** Media Inquiries ***/ .media-inquiries a{ color:#fff; } .mediaInq{ border:2px solid #164790; border-radius:5px; padding:15px; max-width:380px; } /* fix for teams box */ .elementor-2018 .elementor-element.elementor-element-4011872 { --display: flex; --gap: 0px 0px; --background-transition: 0.3s; --padding-block-start: 0px; --padding-block-end: 0px; --padding-inline-start: 0px; --padding-inline-end: 0px; } .elementor-2018 .elementor-element.elementor-element-572da0d { --display: flex; --gap: 0px 0px; --background-transition: 0.3s; --padding-block-start: 0px; --padding-block-end: 0px; --padding-inline-start: 0px; --padding-inline-end: 0px; } .elementor-2018 .elementor-element.elementor-element-bc9ae7d { --display: flex; --gap: 0px 0px; --background-transition: 0.3s; --padding-block-start: 0px; --padding-block-end: 0px; --padding-inline-start: 0px; --padding-inline-end: 0px; } .elementor-2018 .elementor-element.elementor-element-51bed3d { text-align: center; } .elementor-2018 .elementor-element.elementor-element-6e6d479 { --display: flex; --gap: 0px 0px; --background-transition: 0.3s; --padding-block-start: 0px; --padding-block-end: 0px; --padding-inline-start: 0px; --padding-inline-end: 0px; } .elementor-2018 .elementor-element.elementor-element-d9f69ab .ae-element-post-title { text-align: center; font-family: "Archivo", Sans-serif; font-size: 25px; font-weight: 700; line-height: 1.1em; } .elementor-2018 .elementor-element.elementor-element-d9f69ab > .elementor-widget-container { margin: 20px 0px 0px 0px; padding: 0px 0px 0px 0px; } .elementor-2018 .elementor-element.elementor-element-0e94954.ae-acf-field-type-image { text-align: center; } .elementor-2018 .elementor-element.elementor-element-0e94954 .ae-acf-wrapper { text-align: center; } .elementor-2018 .elementor-element.elementor-element-0e94954 .ae-acf-content-wrapper { display: inline-block; } .elementor-2018 .elementor-element.elementor-element-0e94954.ae-align-justify .ae-acf-content-wrapper { width: 100%; text-align: center; } .elementor-2018 .elementor-element.elementor-element-0e94954 .ae-acf-content-wrapper, .elementor-2018 .elementor-element.elementor-element-0e94954 .ae-acf-content-wrapper a, .elementor-2018 .elementor-element.elementor-element-0e94954 span { font-family: "Roboto", Sans-serif; font-size: 18px; font-weight: 400; } .elementor-2018 .elementor-element.elementor-element-0e94954 .ae-acf-content-wrapper, .elementor-2018 .elementor-element.elementor-element-0e94954 .ae-acf-content-wrapper a { color: var( --e-global-color-secondary ); } .elementor-2018 .elementor-element.elementor-element-0e94954 span { color: var( --e-global-color-secondary ); } .elementor-2018 .elementor-element.elementor-element-5b91a93 .ue-simple-popup-overlay { align-items: center; justify-content: center; background-color: rgba(0, 0, 0, 0.50); padding: 20px 20px 20px 20px; } .elementor-2018 .elementor-element.elementor-element-5b91a93 .ue-simple-popup-trigger-wrapper { text-align: center; } .elementor-2018 .elementor-element.elementor-element-5b91a93 .ue-simple-popup-trigger { padding: 5px 5px 5px 5px; border-radius: 5px 5px 5px 5px; font-family: "Roboto", Sans-serif; font-weight: 400; text-decoration: none; background-color: #3e3e3e; color: #ffffff; } .elementor-2018 .elementor-element.elementor-element-5b91a93 .ue-simple-popup-trigger svg { fill: #ffffff; } .elementor-2018 .elementor-element.elementor-element-5b91a93 .ue-simple-popup-btn { flex-direction: row; gap: 0px; } .elementor-2018 .elementor-element.elementor-element-5b91a93 .ue-simple-popup-wrapper { width: 1120px; height: 90vh; padding: 70px 60px 60px 60px; background-color: #ffffff; } .resBox__btn a:link { text-decoration:none; } .elementor-2018 .elementor-element.elementor-element-5b91a93 .ue-simple-popup-close { font-size: 20px; color: #000000; width: 30px; height: 30px; border-radius: 100px 100px 100px 100px; } .elementor-2018 .elementor-element.elementor-element-5b91a93 .ue-simple-popup-close svg { min-width: 20px; fill: #000000; } .white-link a{ color:#ffffff; } /* Blog */ .single-omniabio-blog.ast-page-builder-template .site-main > article { padding-top: 0; padding-left: 0; padding-right: 0; } a.meta-category{ color: #000; text-transform: uppercase; text-decoration: none !important; } .meta-category{ color: #000; text-transform: uppercase; text-decoration: none !important; } h2.blog-post-title { color:#174791; } .meta-author{ color: #0E6F79; } span.meta-author, a { text-decoration: none !important; color:#000; } .meta-date { color: #174791; } .postid-5344 .entry-meta { display:none; } .snf-blog ul li select { height: 40px; padding: 0.3rem 2rem; background-color: #174791; border-color: #fff; border-radius: 10px; text-align:center } .snf-blog ul li * { font-size: 1.1rem!important; font-family: inherit !important; font-weight: 500 !important; color: #fff; -webkit-appearance: none; -moz-appearance: none; appearance: none; } .snf-blog ul .search-filter-reset { padding: 10px 30px; background-color: var(--e-global-color-primary ) !important; color: #fff; transition: all 0.4s ease; border-radius:10px; text-transform:none; } .elementor-kit-15 input[type="submit"]:hover { color: #fff; } .snf-blog ul { padding: 0; margin: 0; display: flex; flex-wrap: wrap; column-gap: 20px; row-gap: 10px; align-items: center; } @media (max-width:768px) { .snf-blog ul { margin:0 0 0 10px; } } // Resource tempate .resource-header { display: flex; align-items: center; margin-left: 0; padding-left: 0!important; } .resource-header .entry-title { margin: 0; } .resource-header .wp-block-button { margin-left: 2rem; } .ast-container .resource-header { padding-left:0; margin-top:2rem; margin-bottom:2rem; } /* Post single template */ [id^="poster-cat-id"].ae-custom-tax { font-size: 18px; font-weight: bold; padding: 10px; background-color: #f5f5f5; border-radius: 5px; } .techposter-img { max-width:550px!important; } [id^="poster-cat-id"].ae-custom-tax .ae-term-item { text-transform: uppercase; display: inline-block; margin-right: 10px; padding: 5px 10px; background-color: #e0e0e0; border-radius: 3px; } /* Poster single template */ [id^="poster-cat-id"].ae-custom-tax, #poster-cat-id .ae-term-item { font-size: 18px; font-weight: bold; text-transform: uppercase; } #poster-cat-id .ae-term-item:not(:first-child)::before { content: " | "; margin-right: 5px; } .post-5339 .entry-meta { display: none; } /* headers */ .single-omniabio-blog p a { color:#108bc8 !important; text-decoration:underline !important; } .single-omniabio-blog .ast-footer-copyright a { color:#fff!important; text-decoration:none!important; } .single-omniabio-blog h1 { color:#174791!important; font-size:3rem!important; } .single-omniabio-blog h2 { color: #209f90!important; font-size:2rem!important; } .single-omniabio-blog h3 { color:#2C2D2C !important; font-size:2.5rem!important; } .single-omniabio-blog h3 a { color:#0051A8; font-size:2.5rem!important; } .single-omniabio-blog h4 { color:#2C2D2C !important; font-size:2.2rem!important; } .single-omniabio-blog h4 a { color:#0051A8; font-size:2.2rem!important; } .single-omniabio-blog h5 { color: #209f90!important; font-size:2rem!important; } .single-omniabio-blog h5 a{ color: #209f90!important; font-size:2rem!important; } .single-omniabio-blog h6 { color: #209f90!important; font-size:1.7rem!important; } .single-omniabio-blog h6 a{ color: #209f90!important; font-size:1.7rem!important; } .yellow-button { background-color:#FEAD00; color:#2C2D2C; } .green-button { color:#fff; background-color:1b8377; } //Featured Blog .featured-omniabio-blog { width: 100%; } .featured-image-cover{ padding-top:10px!important; } .featured-omniabio-blog .featured-image-cover { background-size: cover; background-position: center; background-repeat: no-repeat; width: 100%; } .featured-omniabio-blog .post-content { padding: 20px 0px; } .featured-omniabio-blog .blog-category { color: var(--e-global-color-text ); background-color: #FFFFFF; font-family: "Roboto", Sans-serif; font-size: 1rem; font-weight: 400; text-transform: uppercase; padding: 3px 5px 3px 0px; border-radius: 3px 3px 3px 3px; } .featured-omniabio-blog h3 { font-size: 24px; margin-bottom: 10px; } .featured-omniabio-blog .published-date { color: var(--e-global-color-text ); gap: 0px; width: auto; font-size:1rem; } h2.featured-title a{ color:#174791; font-size:3rem; font-weight:400; } .featured-omniabio-blog .excerpt { color: var(--e-global-color-text ); font-family: "Roboto", Sans-serif; font-weight: 400; margin-top: 10px; } .resources-title h1 { color:#174791; font-size:3rem; } /* Salesforce forms */ div.form-wrapper { border: 0px solid #CCC; padding: 10px; } .e-con-inner.has-form { display: flex !important; flex-wrap: wrap !important; } .e-con-inner.has-form > .main-content-column { width: 66% !important; flex: 0 0 66% !important; max-width: 66% !important; transition: all 0.3s ease; } .e-con-inner.has-form > .form-content-column { width: 33% !important; flex: 0 0 33% !important; max-width: 33% !important; display: block !important; transition: all 0.3s ease; } .e-con-inner.no-form > .main-content-column { width: 100% !important; flex: 0 0 100% !important; max-width: 100% !important; transition: all 0.3s ease; } .e-con-inner.no-form > .form-content-column { display: none !important; } .download-field.ae-visibility-hidden { display: none !important; } @media (max-width: 767px) { .e-con-inner.has-form > .main-content-column, .e-con-inner.has-form > .form-content-column, .e-con-inner.no-form > .main-content-column { width: 100% !important; flex: 0 0 100% !important; max-width: 100% !important; } } /* Relationship content */ .relationship-content-grid { display: grid; grid-template-columns: repeat(auto-fill, minmax(300px, 1fr)); gap: 20px; } .relationship-item { border: 0px solid #e0e0e0; border-radius: 8px; overflow: hidden; } .relationship-item-image img { width: 100%; height: auto; display: block; } .relationship-item-content { padding: 15px; } .relationship-item-title { font-size: 1rem; margin: 0 0 10px; } .relationship-item-title a { color: #000 !important; text-decoration: none; } .relationship-item-date { font-size: 1rem; color: #000; margin: 0 0 10px; } .relationship-item-terms { font-size: 1rem; margin: 0; text-transform:uppercase; } p.relationship-item-terms a { color: #000!important; text-decoration: none !important; } /* Download content type */ .resource-dynamic-title h2{ color:#174791!important; } /* featured date and title */ .published-date { font-weight:bold; } h2.featured-title{ font-weight:400; } /* LinkedIn Share */ .linkedin-button { display: inline-flex; align-items: center; justify-content: center; width: 40px; height: 40px; background-color: #174791; color: white; border-radius: 50%; text-decoration: none; transition: background-color 0.3s ease; } .linkedin-button a { color:#fff!important; } .linkedin-button:hover { background-color: #174791 /* Darker blue on hover */ color: #fff; } .linkedin-button i { font-size: 20px; color:#fff; } /* cftIframe */ #cgtIframe { width: 100%; height: 1950px; border: none; overflow: hidden; } @media screen and (max-width: 1120px) { #cgtIframe { height: 2000px; } } @media screen and (max-width: 991px) { #cgtIframe { height: 2100px; } } @media screen and (max-width: 768px) { #cgtIframe { height:2000px; } } @media screen and (max-width: 500px) { #cgtIframe { height:2200px; } } /* Custom Buttons */ .blue-btn { color:#fff ; font-family: "Roboto", Sans-serif; font-size: 1rem; font-weight: 500; line-height: 16px; background: #004896; padding: 12px 15px 12px 15px; border-radius: 10px 10px 10px 10px; display:inline-block; } .single-omniabio-blog p a.blue-btn { color:#fff !important; text-decoration:none !important; } .purple-btn { color:#fff; font-family: "Roboto", Sans-serif; font-size: 1rem; font-weight: 500; line-height: 16px; background: #3D4E98; padding: 12px 15px 12px 15px; border-radius: 10px 10px 10px 10px;display: inline-block; } .single-omniabio-blog p a.purple-btn { color:#fff !important; text-decoration:none !important; } .green-btn { color:#fff; font-family: "Roboto", Sans-serif; font-size: 1rem; font-weight: 500; line-height: 16px; background: #1B8377; padding: 12px 15px 12px 15px; border-radius: 10px 10px 10px 10px; display:inline-block; } .single-omniabio-blog p a.green-btn { color:#fff !important; text-decoration:none !important; } .yellow-btn { color:#2C2D2C !important; font-family: "Roboto", Sans-serif; font-size: 1rem; font-weight: 500; line-height: 16px; background: #FEAD00; padding: 12px 15px 12px 15px; border-radius: 10px 10px 10px 10px; display:inline-block; } .single-omniabio-blog p a.yellow-btn { color:#2C2D2C !important; text-decoration:none !important; } .related-post-image img{ aspect-ratio: 16/9; /* Adjust ratio as needed */ width: 100%; height: auto; } /* iframe contact */ #iframe-contact { width: 100%; height: 1800px; } @media (max-width: 1200px) { #iframe-contact { height: 1900px; } } @media (max-width: 768px) { #iframe-contact { height: 2250px; } } /* Foot Menu Top Level Links */ #menu-footer-menu li a { font-size: 14px; pointer-events: auto; } </style> </head> <body itemtype='https://schema.org/WebPage' itemscope='itemscope' class="page-template-default page page-id-59 wp-custom-logo wp-embed-responsive ast-desktop ast-page-builder-template ast-no-sidebar astra-4.8.3 group-blog ast-single-post ast-inherit-site-logo-transparent ast-hfb-header elementor-default elementor-kit-15 elementor-page elementor-page-59"> <a class="skip-link screen-reader-text" href="#content" title="Skip to content"> Skip to content</a> <div class="hfeed site" id="page"> <header class="site-header header-main-layout-1 ast-primary-menu-enabled ast-hide-custom-menu-mobile ast-builder-menu-toggle-link ast-mobile-header-inline" id="masthead" itemtype="https://schema.org/WPHeader" itemscope="itemscope" itemid="#masthead" > <div id="ast-desktop-header" data-toggle-type="dropdown"> <div class="ast-above-header-wrap "> <div class="ast-above-header-bar ast-above-header site-header-focus-item" data-section="section-above-header-builder"> <div class="site-above-header-wrap ast-builder-grid-row-container site-header-focus-item ast-container" data-section="section-above-header-builder"> <div class="ast-builder-grid-row ast-builder-grid-row-has-sides ast-builder-grid-row-no-center"> <div class="site-header-above-section-left site-header-section ast-flex site-header-section-left"> <div class="ast-builder-layout-element ast-flex site-header-focus-item ast-header-html-1" 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itemscope="itemscope"> <header class="entry-header ast-no-title ast-header-without-markup"> </header> <!-- .entry-header --> <div class="entry-content clear" itemprop="text"> <div data-elementor-type="wp-page" data-elementor-id="59" class="elementor elementor-59"> <div class="has_ae_slider elementor-element elementor-element-d04a0c2 pageBar pageBar--sm e-flex e-con-boxed ae-bg-gallery-type-default e-con e-parent" data-id="d04a0c2" data-element_type="container" data-settings="{"background_background":"classic"}"> <div class="e-con-inner"> <div class="elementor-element elementor-element-75848d51 pageBar__title elementor-invisible elementor-widget elementor-widget-heading" data-id="75848d51" data-element_type="widget" data-settings="{"_animation":"fadeIn"}" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h1 class="elementor-heading-title elementor-size-default"><span>Regulatory Guidance</span> Throughout Your CMC Journey</h1> </div> </div> <div class="has_ae_slider elementor-element elementor-element-16d374c1 pageBar__info e-flex e-con-boxed ae-bg-gallery-type-default e-con e-child" data-id="16d374c1" data-element_type="container"> <div class="e-con-inner"> <div class="has_ae_slider elementor-element elementor-element-5b60f6ea e-con-full pageBar__infoLeft e-flex ae-bg-gallery-type-default elementor-invisible e-con e-child" data-id="5b60f6ea" data-element_type="container" data-settings="{"animation":"fadeIn","animation_delay":0.200000000000000011102230246251565404236316680908203125}"> <div class="elementor-element elementor-element-7440dffb elementor-widget__width-initial pageBar__infoShape elementor-widget-divider--view-line elementor-widget elementor-widget-divider" data-id="7440dffb" data-element_type="widget" data-widget_type="divider.default"> <div class="elementor-widget-container"> <div class="elementor-divider"> <span class="elementor-divider-separator"> </span> </div> </div> </div> </div> <div class="has_ae_slider elementor-element elementor-element-48997470 pageBar__infoRight e-flex e-con-boxed ae-bg-gallery-type-default elementor-invisible e-con e-child" data-id="48997470" data-element_type="container" data-settings="{"animation":"fadeIn","animation_delay":0.40000000000000002220446049250313080847263336181640625}"> <div class="e-con-inner"> <div class="elementor-element elementor-element-5ed8c1ef pageBar__subTitle elementor-widget elementor-widget-heading" data-id="5ed8c1ef" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <p class="elementor-heading-title elementor-size-default">Our specialized knowledge in CGT regulatory affairs can help de-risk projects at any stage of development. With experience working with regulators around the world, we can deliver customized go-to-market cell therapy regulatory guidance and strategies.</p> </div> </div> </div> </div> </div> </div> </div> </div> <div class="has_ae_slider elementor-element elementor-element-31f02002 devManuf e-flex e-con-boxed ae-bg-gallery-type-default e-con e-parent" data-id="31f02002" data-element_type="container" data-settings="{"background_background":"classic"}"> <div class="e-con-inner"> <div class="elementor-element elementor-element-1094c89c elementor-widget__width-initial elementor-invisible elementor-widget elementor-widget-heading" data-id="1094c89c" data-element_type="widget" data-settings="{"_animation":"fadeIn"}" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h2 class="elementor-heading-title elementor-size-default">Integrated Help at Every Step </h2> </div> </div> <div class="elementor-element elementor-element-27a3890e elementor-widget__width-initial elementor-invisible elementor-widget elementor-widget-text-editor" data-id="27a3890e" data-element_type="widget" data-settings="{"_animation":"fadeIn","_animation_delay":0.200000000000000011102230246251565404236316680908203125}" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>We offer a full suite of cell therapy regulatory guidance consultation:</p> </div> </div> <div class="elementor-element elementor-element-a061288 oList elementor-widget__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list" data-id="a061288" data-element_type="widget" data-widget_type="icon-list.default"> <div class="elementor-widget-container"> <ul class="elementor-icon-list-items"> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <i aria-hidden="true" class="fas fa-square-full"></i> </span> <span class="elementor-icon-list-text">Interpretation and explanation of regulatory context</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <i aria-hidden="true" class="fas fa-square-full"></i> </span> <span class="elementor-icon-list-text">Assistance in developing regulatory plans to drive the commercialization strategy</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <i aria-hidden="true" class="fas fa-square-full"></i> </span> <span class="elementor-icon-list-text">Reduction of regulatory unknowns in project planning</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <i aria-hidden="true" class="fas fa-square-full"></i> </span> <span class="elementor-icon-list-text">Guidance and support throughout the preparation and submission process, including leading interactions with regulators such as US FDA and Health Canada</span> </li> <li class="elementor-icon-list-item"> <span class="elementor-icon-list-icon"> <i aria-hidden="true" class="fas fa-square-full"></i> </span> <span class="elementor-icon-list-text">Regulatory support for manufacturing under GMP, including drafting and reviewing CMC sections of the regulatory submission</span> </li> </ul> </div> </div> <div class="has_ae_slider elementor-element elementor-element-58a5137d dmCont e-flex e-con-boxed ae-bg-gallery-type-default e-con e-child" data-id="58a5137d" data-element_type="container"> <div class="e-con-inner"> <div class="has_ae_slider elementor-element elementor-element-152735a8 dmCont__row e-flex e-con-boxed ae-bg-gallery-type-default elementor-invisible e-con e-child" data-id="152735a8" data-element_type="container" data-settings="{"animation":"fadeIn","animation_delay":0.200000000000000011102230246251565404236316680908203125}"> <div class="e-con-inner"> <div class="has_ae_slider elementor-element elementor-element-158b9c2b dmCont__col dmCont__col1 e-flex e-con-boxed ae-bg-gallery-type-default e-con e-child" data-id="158b9c2b" data-element_type="container"> <div class="e-con-inner"> <div class="elementor-element elementor-element-3ea82847 elementor-widget elementor-widget-heading" data-id="3ea82847" data-element_type="widget" data-widget_type="heading.default"> <div class="elementor-widget-container"> <h2 class="elementor-heading-title elementor-size-default">A Successful Track Record of Compliance</h2> </div> </div> <div class="elementor-element elementor-element-5de9617b elementor-widget elementor-widget-text-editor" data-id="5de9617b" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <p>Powered by CCRM, we have a proven track record of navigating the regulatory landscape. We do so by working as an extension of your team. Our comprehensive regulatory plans identify efficiencies in time and resources, leading to the best outcome as fast as possible.</p> </div> </div> <div class="elementor-element elementor-element-2cf4cef3 elementor-widget elementor-widget-button" data-id="2cf4cef3" data-element_type="widget" data-widget_type="button.default"> <div class="elementor-widget-container"> <div class="elementor-button-wrapper"> <a class="elementor-button elementor-button-link elementor-size-sm" href="/contact/"> <span class="elementor-button-content-wrapper"> <span class="elementor-button-text">Get Your Products To Patients</span> </span> </a> </div> </div> </div> </div> </div> <div class="has_ae_slider elementor-element elementor-element-2d1821b0 dmCont__col dmCont__col2 e-flex e-con-boxed ae-bg-gallery-type-default e-con e-child" data-id="2d1821b0" data-element_type="container"> <div class="e-con-inner"> <div class="elementor-element elementor-element-6bc6698d elementor-widget elementor-widget-image" 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In a project that achieved cost-effective manufacturing under tight timelines, our team delivered as a CDMO partner for clinical-phase manufacturing of a natural killer (NK) cell product for <a href="https://www.nkartatx.com">Nkarta</a>.</p> </div> </div> <div class="elementor-element elementor-element-6f56546e elementor-widget elementor-widget-button" data-id="6f56546e" data-element_type="widget" data-widget_type="button.default"> <div class="elementor-widget-container"> <div class="elementor-button-wrapper"> <a class="elementor-button elementor-button-link elementor-size-sm" href="/wp-content/uploads/2023/08/NKarta_Case_Study-FINAL.pdf" target="_blank"> <span class="elementor-button-content-wrapper"> <span class="elementor-button-text">Read this full case study</span> </span> </a> </div> </div> </div> </div> </div> </div> <div class="has_ae_slider elementor-element elementor-element-7649b749 e-flex e-con-boxed ae-bg-gallery-type-default e-con e-parent" data-id="7649b749" 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