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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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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
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Pre/Post Correspondence and Authorized Communication

Masuu US Agent streamlines Pre/Post Correspondence Authorized Communication with USFDA, handling queries, deficiencies, and inspections.
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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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USFDA Electronic Submission Gateway, USFDA ESG portal setup

Masuu US Agent provides expert support for secure, compliant regulatory submissions via the USFDA Electronic Submission Gateway (ESG) portal.
https://www.masuuglobal.com/associate-regulatory-services/usfda-esg-portal-setup-assistance/ - Details - Similar

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

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.
https://www.masuuglobal.com/associate-regulatory-services/gdufa-self-identification-assistance/ - Details - Similar

Food facility registration, FDA food facility registration, FDA FFR

Masuu US Agent provides expert help for pharma companies with USFDA Food Facility Registration, ensuring compliance efficient renewals.
https://www.masuuglobal.com/associate-regulatory-services/food-facility-registration-assistance/ - Details - Similar

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