USFDA ESG Portal Setup Assistance
The USFDA Electronic Submission Gateway (ESG) allows for the secure submission of various regulatory documents, including New Drug Applications (NDA), Biologics License Applications (BLA), Abbreviated New Drug Applications (ANDA), Investigational New Drug Applications (IND), Drug Master Files (DMF), Premarket Approval Applications (PMA), 510(k) notifications, annual reports, post-marketing reports, orphan drug designation requests, and general correspondence.
These submissions are managed by different FDA centers: the Center for Drug Evaluation and Research (CDER) for drugs, the Center for Biologics Evaluation and Research (CBER) for biologics, and the Center for Devices and Radiological Health (CDRH) for medical devices.
Masuu US Agent assists pharmaceutical companies in setting up the ESG portal by providing comprehensive support, including the procurement of digital certificates for secure communication, secure email setup, non-repudiation letter preparation, test account setup, compliance testing, load testing, and live submission support.
This ensures that all submissions are compliant with FDA guidelines and technical standards, facilitating smooth and secure dossier and eCTD submissions to the USFDA.