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The FDA was requiring e-submissions be set up through the FDA portal.  Ashfield Pharmacovigilance determined that this process would take approximately four hours per client.  Seventeen clients needed to be set up with e-submission portals, each having four separate users needing their own account.  The deadline to have this completed by was September 12, 2015.


In order to accomplish this, our internal team had to get letters of authorization for each client stating that Ashfield Pharmacovigilance could submit on their behalf.  Once the authorization letters were sent to the FDA, Ashfield Pharmacovigilance had to request accounts for each client and each user from the FDA – all of which required a separate correspondence.  Once test accounts were created, trading certificated had to be generated per user.  After the FDA came back with the test accounts and certificates, multiple rounds of testing had to be completed, testing multiple levels of complexity and various forms of data.  Once the testing was complete and the process was smoothed, a working practice and user manual was created.


Ashfield Pharmacovigilance completed all testing and all client e-submission portals were created within the required timeframe.  All post marketing submissions are currently running smoothly, and Ashfield Pharmacovigilance is now electronically submitting PADERS and medical device reports. The e-submissions process has allowed for a more efficient, streamlined, and secure way of submitting documents to the FDA.

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