Electronic Submission Gateway Services

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.

Have WebTrader outages impacted your submission schedule? Our AS2 technology has remained operational through every WebTrader outage. We will immediately improve the reliability of your electronic submission infrastructure.

Outsourced ESG Submission Processing Services

FDA Product Submissions
  1. Send ThinSpring three signed copies of a Letter of Authorization on your company's letterhead.
    Click here for an example
    Then mail the three copies to:
    Attn: LOA
    P.O. Box 7096
    Watchung, NJ 07069
  2. There are three ways in which we handle submission requests, you choose one of the three.
    1. Upon completion of a conversion project by us, we will ask for your permission to submit.
    2. Upon completion by you, using our software service, you send us your submission request.
    3. You securely upload the files to our system that you want submitted, then send us your submission request.
  3. ThinSpring processes your submission.
    1. First, we process the submission on your behalf.
    2. Then, we monitor submission receipts and shepherd any Manual Override Requests with the regulatory agency, if required.
    3. Finally, we deliver the electronic receipts from the regulatory agency.

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