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Regulatory One: GDUFA AND ITS CONSEQUENCES

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http://www.regulatoryone.com/2013/03/gdufa-and-its-consequences.html - Details - Similar

GDUFA self identification, Generic Drug User Fee Amendments

Masuu US Agent offers expert GDUFA self-identification services for pharma, ensuring compliance with FDA annual facility requirements.
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Regulatory One

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FDA Controlled Correspondence Assistance, FDA CC Submission

Masuu US Agent helps with FDA Controlled Correspondence for generic drug development, ensuring regulatory clarity and approval.
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SPL/SPM Services, FDA SPL submissions , SPM Format

Masuu Global specializes in SPL/SPM conversion services for USFDA ANDA, NDA, BLA Health Canada submissions, ensuring compliance accuracy.
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FDA Fee Schedule 2025 Impact on API Suppliers

Learn about FDA’s 2025 user fee schedule and its implications for API suppliers and global pharma operations.
http://resources.pharmalinkage.com/industry-news/fda-announces-new-user-fee-schedule-for-fy-2025-drug-companies/ - Details - Similar

FDA Establishment Identifier (FEI), FDA FEI Registration

Masuu US Agent offers FDA FEI registration for pharma companies, ensuring you gets your FDA Establishment Identifier (FEI) number stay compliant.
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Language Translation service, Native language translators

Masuu Global provides accurate, culturally resonant language translation for diverse industries in Spanish, German, Russian, Chinese more,
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Expert Toxicologists for Detailed PDE, OEL OEB Value Reports

Masuu Global’s toxicologists offer precise PDE, OEL OEB value reports with thorough literature searches, ensuring compliance and approval.
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Expert EU MAH QP Services for Pharma, MAH Services, EU QP

Masuu Global provides EU MAH QP services, including audit support, dossier filing, and regulatory compliance for pharma companies.
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