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NDC labeler code, NHRIC Labeler Code, National Drug Code

Masuu US Agent offers expert NDC/NHRIC labeler code services for pharma, ensuring compliance and securing your FDA-assigned code efficiently.
https://www.masuuglobal.com/associate-regulatory-services/ndc-nhric-labeler-code-assistance/ - Details - Similar

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.
https://www.masuuglobal.com/labeling-artwork/usfda-spl-and-health-canada-spm/ - Details - Similar

Regulatory Review, Authoring Dossier Compilation Services

Masuu Global s regulatory review, authoring, and dossier compilation services for global health authorities, including US ANDA, NDA, BLA more.
https://www.masuuglobal.com/regulatory-affairs/review-authoring-dossier-compilation/ - Details - Similar

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.
https://www.masuuglobal.com/associate-regulatory-services/eu-mah-and-qp-services-assistance/ - Details - Similar

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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Language Translation service, Native language translators

Masuu Global provides accurate, culturally resonant language translation for diverse industries in Spanish, German, Russian, Chinese more,
https://www.masuuglobal.com/associate-regulatory-services/global-language-translation-assistance/ - Details - Similar

EU EMA/EDQM SPOR ID Registration and Compliance

Masuu Global offers expert help for ORG_ID and LOC_ID registration in SPOR, ensuring EU EMA/EDQM compliance and efficiency.
https://www.masuuglobal.com/associate-regulatory-services/eu-ema-edqm-spor-assistance/ - Details - Similar

Masuu US Agent: Pre-Assigned Application Numbers Tracking

Masuu US Agent aids foreign pharma in obtaining pre-assigned application numbers (ANDA, NDA, BLA) via the USFDA’s CDER NextGen portal for smooth tracking.
https://www.masuuglobal.com/associate-regulatory-services/application-number-assignment/ - Details - Similar

FDA submission documents, FDA regulatory submissions, FDA Submission

Masuu US Agent provides FDA submission document authorization for foreign pharma, ensuring compliance with USFDA regulations endorsed forms
https://www.masuuglobal.com/associate-regulatory-services/fda-submission-form-authorization/ - Details - Similar

Pre/Post Correspondence and Authorized Communication

Masuu US Agent streamlines Pre/Post Correspondence Authorized Communication with USFDA, handling queries, deficiencies, and inspections.
https://www.masuuglobal.com/associate-regulatory-services/pre-post-correspondence-and-authorized-communication/ - Details - Similar

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