ScienTek Software eStability Suite

Electronic Submission of Pharmaceutical Stability Data to the FDA

The FDA will require stability information to be submitted electronically in XML format, a project known as eStability. Instead of producing and submitting formatted data tables, data analysis reports, and graphs in paper or PDF, pharmaceutical companies will be required to produce and submit eStability XML files from their stability studies.

ScienTek Software, Inc. now has developed an exciting eStability Suite of applications to help the pharmaceutical and related industries prepare such XML files for submission to the FDA. With the eStability XML file as a universal file format to carry the stability information, our suite of applications can also serve as universal tools for reporting and data analysis no matter where the stability information comes from. Read More...