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/
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Adopted March 2001 Revised March 2024
https://www.mtna.org/MTNA/Explore_MTNA/Bylaws/MTNA/Explore_MTNA/Bylaws.aspx?hkey=4ec115dd-763c-4a13-a838-5697d82c2176
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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/
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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/
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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/
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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/
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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/
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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/
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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/
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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/
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