The physical transmission of submission files to regulatory agencies, and the electronic receipts associated with those files, are critical components of a submission life cycle. The submission is not complete until the receipts from the agency are received without error and the appropriate agency databases have been updated. We provide outsourced submission processing services using ThinSpring's AS2 Server technology. AS2 (Applicability Statement 2) is a specification about how to transport data securely and reliably over the Internet. Security is achieved by using digital certificates and encryption. Our software is based on OpenAS2 technology and is directly connected with the FDA, allowing us to process in real-time. We can also handle bulk or high-volume submissions quickly and efficiently. Health Canada - HC, shares this same gateway with the FDA, so we also provide these submission services as well.
Outsourced ESG Submission Processing Services
We currently support all known FDA submission types accepted by the Electronic Submission Gateway. This gateway also
services Health Canada so we can also provide HC submissions.
Click here for a list of the current submission types