Application Number Assignment
Masuu US Agent assists foreign pharmaceutical companies in obtaining pre-assigned application numbers for their ANDA, NDA, BLA, DMF, and IND submissions through the USFDA’s CDER NextGen portal.
By providing the requested information as per USFDA guidance, Masuu secures these unique 6-digit numbers, which are essential for the identification and tracking of applications throughout the review process.
This service ensures that companies can efficiently navigate the regulatory landscape, facilitating smooth submission and review of their applications by the USFDA.