{"id":147,"date":"2022-10-03T11:24:19","date_gmt":"2022-10-03T11:24:19","guid":{"rendered":"https:\/\/theragent.com\/?page_id=147"},"modified":"2024-02-06T19:15:05","modified_gmt":"2024-02-06T19:15:05","slug":"regulatory-affairs","status":"publish","type":"page","link":"https:\/\/theragent.com\/services\/regulatory-affairs\/","title":{"rendered":"Regulatory Affairs"},"content":{"rendered":"<header id=\"image-header-block-block_0ba9b8586a8ab517acd8fc2dacb1da79\" class=\"image-header-block style-text-left-angle-bg height-default\">\n    <div class=\"bg\" style=\"background-image:url(https:\/\/theragent.com\/wp-content\/uploads\/2022\/10\/Hero-Reg-Affairs-2000x841.jpg); background-position: 50% 50%;\"><\/div>\n    <div class=\"text\"><div>\n        <div>\n            <div class=\"pre-headline\">Regulatory Affairs<\/div>                        <h3>Providing strategic regulatory guidance every step of the way.<\/h3>            <p>Scientific expertise to develop, optimize, and implement your manufacturing process is a critical CDMO contribution. However, at Theragent we don\u2019t overlook the positive impact that a sound regulatory strategy can have on our sponsors. This is why we offer our clients strategic regulatory guidance to help you de-risk your project \u2013 whether you are in early preclinical stages or moving towards commercialization of your cell or gene therapy.<\/p>\n                    <\/div>\n            <\/div><\/div>\n<\/header>\n\n\n<div class=\"wp-block-group is-style-small-centered has-light-gray-background-color has-background is-layout-flow wp-block-group-is-layout-flow\">\n<h3 class=\"wp-block-heading\">The Approach<\/h3>\n\n\n\n<p>The foundation of Regulatory Affairs is to stay current with emerging global standards for advanced therapies. From that foundation, we leverage our experience to apply a Quality-by-Design mentality to our work. This risk-based approach will ensure that our development of both analytical and manufacturing processes will consistently fall within a properly validated design space, thereby ensuring your product has a clear regulatory path with CMC life cycle management in mind.<\/p>\n<\/div>\n\n\n<div id=\"four-lists-block-block_66297dd78acdec9c1bb4560caac9f606\" class=\"four-lists-block\"><div>\n                <div class=\"list list-1\">\n                <aside>1<\/aside>\n                <div>\n                    <h4>Global Regulatory Standards<\/h4>\n                    <p>We stay up to date on all current global regulatory standards, so you don\u2019t have to<\/p>                <\/div>\n            <\/div>\n                    <div class=\"list list-2\">\n                <aside>2<\/aside>\n                <div>\n                    <h4>Define Regulatory Pathway<\/h4>\n                    <p>We perform GAP assessments to ensure you have a fully formed regulatory strategy from concept to commercialization<\/p>                <\/div>\n            <\/div>\n                    <div class=\"list list-3\">\n                <aside>3<\/aside>\n                <div>\n                    <h4>QBD and Risk-based Approach<\/h4>\n                    <p>From study design support, to advising on phase-appropriate GMP\u2019s, we ensure your product follows a risk-based approach<\/p>                <\/div>\n            <\/div>\n                    <div class=\"list list-4\">\n                <aside>4<\/aside>\n                <div>\n                    <h4>Life Cycle Management<\/h4>\n                    <p>Our risk-based approach and CMC product lifecycle expertise improves regulatory predictability while saving you time<\/p>                <\/div>\n            <\/div>\n        <svg class=\"svg-icon logo-plus\" width=\"24\" height=\"24\" aria-hidden=\"true\" role=\"img\" focusable=\"false\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" x=\"0px\" y=\"0px\" viewBox=\"0 0 64 64\"><path d=\"M0.7,32.7c0,1.7,1.3,3.1,3.1,3.1c1.7,0,3.2-1.3,3.2-3c0-1.7-1.3-3.1-3.1-3.2C2.1,29.6,0.7,31,0.7,32.7\"\/><path d=\"M32.5,22.2c-2.1,0-3.7,1.7-3.7,3.7c0,2.1,1.7,3.7,3.7,3.7c2,0,3.7-1.6,3.7-3.7C36.3,23.9,34.6,22.2,32.5,22.2\" \/><path d=\"M46.3,29.1c-2.1,0-3.7,1.7-3.7,3.7c0,2.1,1.7,3.7,3.7,3.7c2,0,3.7-1.6,3.7-3.7C50,30.7,48.3,29.1,46.3,29.1\"\/><path d=\"M17.7,29.1c-2,0-3.7,1.7-3.7,3.7c0,2.1,1.7,3.7,3.7,3.7c2.1,0,3.7-1.6,3.7-3.7C21.4,30.7,19.8,29.1,17.7,29.1\" \/><path d=\"M32.5,35.9c-2.1,0-3.7,1.6-3.7,3.7c0,2,1.7,3.7,3.7,3.7c2,0,3.7-1.6,3.7-3.7C36.3,37.5,34.6,35.9,32.5,35.9\"\/><path d=\"M31.5,6.5l0,3.6c-0.2,0-0.3,0.1-0.5,0.2c-1.4,0.8-1.9,2.5-1.2,3.9c0.8,1.4,2.6,1.9,4,1.1 c1.4-0.8,1.9-2.5,1.1-3.9c-0.4-0.7-1-1.1-1.7-1.4l0.1-3.5c0.3-0.1,0.6-0.2,0.9-0.3c1.6-0.9,2.1-2.8,1.2-4.4 c-0.9-1.5-2.8-2.1-4.4-1.2c-1.6,0.9-2.2,2.8-1.3,4.4C30.1,5.7,30.8,6.3,31.5,6.5\"\/><path d=\"M63.3,32.8c0-1.7-1.3-3.1-3.1-3.2c-1.7,0-3.2,1.3-3.2,3c0,1.7,1.3,3.1,3,3.1C61.9,35.9,63.3,34.5,63.3,32.8\"\/><path d=\"M32.5,47.5c-2,0-3.6,1.6-3.6,3.5c0,2,1.6,3.5,3.6,3.5c1.9,0,3.6-1.6,3.6-3.5C36.1,49.1,34.5,47.5,32.5,47.5\"\/><path d=\"M32.5,57.3c-1.8,0-3.3,1.5-3.3,3.2c0,1.8,1.5,3.2,3.3,3.2c1.8,0,3.3-1.4,3.3-3.2 C35.8,58.7,34.3,57.3,32.5,57.3\"\/><\/svg><\/div><\/div>\n\n\n<div id=\"col-w-angle-image-block-block_8c27bba5fd92fb02a43775b118e83b04\" class=\"col-w-angle-image-block style-image-right image-adj--10\">\n        <div class=\"colwai-image\" style=\"background-image: url(https:\/\/theragent.com\/wp-content\/uploads\/2022\/10\/Regulatory-Affairs-1800x982.jpg); background-position: 10% 50%;\"><\/div>\n    <div class=\"colwai-copy\"><div><div>\n        <h3>Regulatory Affairs<\/h3>\n<p>We offer strategic guidance to our clients and offer cell and gene therapy IND filing support. To maximize clinical trial manufacturing success rates, we dive deep into the details of study design to ensure we are developing methods and processes with operating parameters that fall within an ideal, validated design space. From the big picture down to the execution details, our Regulatory Affairs team can help improve the regulatory predictability of your product.<\/p>\n    <\/div><\/div><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Scientific expertise to develop, optimize, and implement your manufacturing process is a critical CDMO contribution. However, at Theragent we don\u2019t overlook the positive impact that a sound regulatory strategy can have on our sponsors. This is why we offer our clients strategic regulatory guidance to help you de-risk your project \u2013 whether you are in early preclinical stages or moving towards commercialization of your cell or gene therapy.<\/p>\n","protected":false},"author":1,"featured_media":505,"parent":21,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"acf":[],"_links":{"self":[{"href":"https:\/\/theragent.com\/wp-json\/wp\/v2\/pages\/147"}],"collection":[{"href":"https:\/\/theragent.com\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/theragent.com\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/theragent.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/theragent.com\/wp-json\/wp\/v2\/comments?post=147"}],"version-history":[{"count":7,"href":"https:\/\/theragent.com\/wp-json\/wp\/v2\/pages\/147\/revisions"}],"predecessor-version":[{"id":916,"href":"https:\/\/theragent.com\/wp-json\/wp\/v2\/pages\/147\/revisions\/916"}],"up":[{"embeddable":true,"href":"https:\/\/theragent.com\/wp-json\/wp\/v2\/pages\/21"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/theragent.com\/wp-json\/wp\/v2\/media\/505"}],"wp:attachment":[{"href":"https:\/\/theragent.com\/wp-json\/wp\/v2\/media?parent=147"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}