Overview
Global Regulatory Partners (“GRP”) announced the successful ANVISA approval of Beyonttra® (acoramidis) in Brazil, achieved through its role as the local regulatory representative and Marketing Authorization Holder (MAH).
Introduction
Developed by BridgeBio Pharma, Beyonttra® is indicated for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM), a rare, progressive, and life-threatening 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.
Enabling Market Access Through Local Regulatory Expertise
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.
Acted as the local legal and regulatory representative in Brazil.
Managed the regulatory submission and ongoing engagement with ANVISA.
Ensured compliance with all Brazilian regulatory requirements.
Supported ANVISA GMP inspection
About Global Regulatory Partners
Global Regulatory Partners is a global regulatory affairs and market access organization enabling pharmaceutical, biotechnology, MedTech, and consumer product companies to navigate complex regulatory pathways throughout the product lifecycle. GRP provides integrated, end-to-end regulatory and compliance capabilities, including local representation and quality oversight, supporting efficient and compliant global market entry across key global markets.
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For more information on regulatory solutions and market access: www.globalregulatorypartners.com
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Telephone : (+1) 781-672-4200
References
Learn more about Anvisa.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.