Your development work hinges on the ability to gain approval to move forward. Making quality timely submissions is key to maintaining your timeline and meeting your milestones. It is more imperative than ever to have an experienced submissions group. As of May 15, 2018, the U.S. Food and Drug Administration requires that submissions be done via electronic submission which will require a comprehensive and integrated approach. Omni-EDS can assist with regulatory document management and submission of:
- Investigational New Drug (IND's) applications
- Drug Master File (DMF)
- New Drug Application (NDA)
- Abbreviated New Drug Application (ANDA)
- Biologic License Application (BLA), and
- And subsequent submissions to these types of applications, including clinical study reports, annual reports, amendments, supplements, and other reports.