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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: GDUFA AND ITS CONSEQUENCES

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

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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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.
https://www.masuuglobal.com/associate-regulatory-services/fei-registration-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.
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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

Cosmetic MoCRA registration, FDA Cosmetic product registration

Masuu offers expert Cosmetic MoCRA registration to ensure FDA compliance with facility registration and product listing requirements.
https://www.masuuglobal.com/associate-regulatory-services/cosmetic-mocra-registration-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

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

CARES Act Submission, FDA CDER NextGen portal, CARES Act

Masuu US Agent offers expert CARES Act submission help, ensuring accurate CSV reporting via the FDA CDER NextGen portal for compliance.
https://www.masuuglobal.com/associate-regulatory-services/cares-act-submission-assistance/ - Details - Similar

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