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).
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 inspections.
“This approval underscores the importance of strong local regulatory expertise in enabling access to innovative therapies,” said Suzan Davis, Chief Executive Officer of Global Regulatory Partners. “We are proud to support companies bringing critical treatments to patients with rare diseases through compliant and efficient regulatory pathways.”
ABOUT GLOBAL REGULATORY PARTNERS
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.
To learn more about Global Regulatory Partners and its services in Japan, visit globalregulatorypartners.co.jp
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