Are You Prepared To Meet The Mandatory eSubmission Deadline Of June 10, 2015? Or Do You Run The Risk of Being Non-compliant With The FDA?

Imroz Adeeb

The FDA’s rule on providing submissions for post-marketing safety reports in electronic format becomes effective on June 10, 2015.

The US FDA amended its post-marketing safety reporting regulations for human drug and biological products in June of last year; requiring MHA’s to submit their safety reports in an electronic format. The FDA has taken this measure to improve its systems for collecting and analyzing post-marketing safety reports in the hope to speed up:

  • The review of post-marketing safety reports
  • The identification of emerging safety problems
  • The dissemination of safety information to the public

In addition, the amendments will be a key element in harmonizing the FDA’s post-marketing safety reporting regulations with international standards for the electronic submission of safety information.

Since this rule will be effective on June 10th 2015, your organization has just 45 business days left to comply.

Are you prepared?

If you are not prepared to meet the deadline, Sciformix can help. Based on these mandatory parameters and depending on the complexity of your data, Sciformix can offer a customized solution that can be implemented before the 10th of June. Our proven drug safety platform will have your eSubmission solution setup in as little as 30 business days* and involves:

  1. Preparing and configuring your safety database
  2. Validating the database in accordance with 21 CFR Part 11
  3. Setting up your eSubmission gateway
  4. Swift data migration*

Your solution includes:

  • End-to-end pharmacovigilance services from database hosting till signal detections (including contact center, ICSR processing, medical review and authoring aggregate report) with regulatory reporting via Electronic Submission Gateway (ESG)
  • Highly skilled employees, including pharmacists, registered nurses, specialist doctors, MDs and PhDs
  • LEAN processes and a flexible engagement model that helps achieve higher quality and compliance with cost benefits
  • A Quality Management System (QMS) that ensures audit readiness and compliance to regulations

*Conditions Apply
For more information write to us at ask@sciformix.com or call us on 1 (877) 576-5005.