Pre/Post Correspondence and Authorized Communication

Pre/Post Correspondence and Authorized Communication

Pre/Post Correspondence and Authorized Communication : Masuu US Agent acts as an authorized agent to facilitate communication between the USFDA and the foreign Pharmaceutical companies, as outlined in 21 CFR 207.69.

Masuu US Agent communicate any queries or deficiencies such as Discipline Review Letter (DRL), Information Request (IR), Complete Response Letter (CR) identified by the USFDA in various types of applications, including Drug Master Files (DMF), Abbreviated New Drug Applications (ANDA), Investigational New Drug (IND) applications, New Drug Applications (NDA), Cosmetic Products, OTC Monograph Products, Food Products and Registration, 510K Application and Medical Device Listing.

This involves providing responses and additional information required during both initial submissions and throughout the lifecycle of the applications.

Masuu US Agent communicates with USFDA to schedule inspections/audits for foreign pharmaceutical companies.