{"id":1988,"date":"2026-05-13T17:23:22","date_gmt":"2026-05-13T08:23:22","guid":{"rendered":"https:\/\/globalregulatorypartners.co.jp\/?post_type=news&#038;p=1988"},"modified":"2026-05-13T19:01:36","modified_gmt":"2026-05-13T10:01:36","slug":"global-regulatory-partners-supports-anvisa-approval-of-orphan-therapy-beyonttra-in-brazil","status":"publish","type":"news","link":"https:\/\/globalregulatorypartners.co.jp\/en\/news\/global-regulatory-partners-supports-anvisa-approval-of-orphan-therapy-beyonttra-in-brazil\/","title":{"rendered":"Global Regulatory Partners Supports ANVISA Approval of Orphan Therapy Beyonttra\u00ae in Brazil"},"content":{"rendered":"\n<p>Global Regulatory Partners (&#8220;GRP&#8221;) announced the successful ANVISA approval of Beyonttra\u00ae (acoramidis) in Brazil, achieved through its role as the local regulatory representative and Marketing Authorization Holder (MAH).<\/p>\n\n\n\n<p>Developed by BridgeBio Pharma, Beyonttra\u00ae is indicated for the treatment of transthyretin amyloid cardiomyopathy (ATTR\u2011CM), a rare, progressive, and life\u2011threatening cardiac condition. The product has been granted orphan drug designation in Brazil, highlighting its importance in addressing unmet medical needs for patients with rare diseases.<\/p>\n\n\n\n<p class=\"has-text-color has-link-color has-medium-font-size wp-elements-cb01ba959100ecc502a592ab5a01f75f\" style=\"color:#4476c6\"><strong>Enabling Market Access Through Local Regulatory Expertise<\/strong><\/p>\n\n\n\n<p>In Brazil, regulatory approval requires a locally established legal entity to hold the marketing authorization and interface directly with ANVISA. Through its Brazilian entity, Global Regulatory Partners fulfilled this requirement, enabling a compliant and efficient pathway to approval.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Acted as the local legal and regulatory representative in Brazil.<\/li>\n\n\n\n<li>Managed the regulatory submission and ongoing engagement with ANVISA.<\/li>\n\n\n\n<li>Ensured compliance with all Brazilian regulatory requirements.<\/li>\n\n\n\n<li>Supported ANVISA GMP inspections.<\/li>\n<\/ul>\n\n\n\n<p class=\"has-background\" style=\"background-color:#cae2ff\"><em>\u201cThis approval underscores the importance of strong local regulatory expertise in enabling access to innovative therapies,\u201d <strong>said Suzan Davis, Chief Executive Officer of Global Regulatory Partners<\/strong>. \u201cWe are proud to support companies bringing critical treatments to patients with rare diseases through compliant and efficient regulatory pathways.\u201d<\/em><\/p>\n\n\n\n<p><strong>ABOUT GLOBAL REGULATORY PARTNERS<\/strong><br>Global Regulatory Partners (GRP) is a leading provider of integrated regulatory affairs, compliance, and commercialization solutions for pharmaceutical, biotechnology, and medical device companies entering Japan. By serving as a Market Authorization Holder (MAH) in Japan, GRP simplifies market entry, accelerates regulatory approval timelines, and enables faster patient access to innovative healthcare products throughout the product lifecycle.<\/p>\n\n\n\n<p>To learn more about Global Regulatory Partners and its services in Japan, visit <a href=\"https:\/\/globalregulatorypartners.co.jp\/en\/\">globalregulatorypartners.co.jp<\/a><\/p>\n\n\n\n<p>To download a copy of this press release, click <strong><a href=\"https:\/\/globalregulatorypartners.co.jp\/wp-content\/uploads\/2026\/05\/Beyonttra-Approval-GRP_Branded_Press_Release_Website-final-sd.pdf\">HERE<\/a><\/strong>.<\/p>\n\n\n\n<p><\/p>\n","protected":false},"featured_media":0,"template":"","categories":[19],"class_list":["post-1988","news","type-news","status-publish","hentry","category-press-release"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ 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