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DUNS Number registration, DUNS Number, DUNS Registration

Masuu US Agent specializes in DUNS number registration, helping pharma firms obtain or update numbers for efficient USFDA compliance.
https://www.masuuglobal.com/associate-regulatory-services/duns-number-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

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

FDA Controlled Correspondence Assistance, FDA CC Submission

Masuu US Agent helps with FDA Controlled Correspondence for generic drug development, ensuring regulatory clarity and approval.
https://www.masuuglobal.com/associate-regulatory-services/controlled-correspondence-assistance/ - 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://masuuglobal.com/associate-regulatory-services/pre-post-correspondence-and-authorized-communication/ - 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

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://masuuglobal.com/associate-regulatory-services/fda-submission-form-authorization/ - 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

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://masuuglobal.com/associate-regulatory-services/application-number-assignment/ - 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

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