Facility Establishment Registration (ER) Assistance
To maintain an active firm registration status with the USFDA, pharmaceutical companies must submit or update their FDA Establishment Registration (ER) Structured Product Labeling (SPL) annually.
This process, mandated by 21 CFR 207.21, requires registration renewal between October 1 and December 31 each year. Failure to renew by December 31 results in the USFDA considering the firm inactive, leading to removal from the FDA database and potential compliance issues.
Masuu US Agent assists pharmaceutical companies in navigating this critical process, ensuring timely and accurate Drug FDA Establishment Registration (ER) and renewal with the USFDA. Our services include comprehensive guidance on the required documentation, preparation of the SPL submission, and management of the entire registration process.
This applies to all companies involved in manufacturing, wwwing, or related activities. By staying compliant with the annual ER requirements, firms can avoid disruptions in their operations and maintain their status within the USFDA database.