Our electronic competencies have grown and we continue to expand our knowledge base in harmony with FDA’s new initiatives. We submit electronic INDs and DMFs. We use eSubmitter for Center for Veterinery Medicine. But more than the operational component, we have completed successful filings for drug-device combinations, excipient DMFs, device Master Files, and Index Listings via CVM’s Office of Minor Use Minor Species (MUMs).
- Managed ESG Client Accounts
- Secure Cloud File Exchange
- Secure Cloud Project and Task Manager
- Current XML eCTD Publisher
- Current XML eCTD Validator
- eSubmitter
- Document Management System (Cloud and Premises)
- Off-site Multiple Backup Systems (Cloud)
- Project Management Tools (Cloud)