The daily business of regulatory professionals involves processing of complex information from inside business and authorities. Today’s validated IT solutions are usually not flexible enough to keep pace with the ever-changing regulatory environment and the need for on-the-spot information. We build RA intelligence tools based on our day-to-day work experience. Our RA consultants translate specific tasks e.g. variation classification into flexible and versatile solutions like the mobile App RegChange.
In this tool, the EU classification guideline is broken down into the individual changes, greatly simplifying navigation through the document. Conditions, notes and documentation requirements directly connected to the selected change and Article 5 changes are included.
Note: RegChange has been made publicly available by the BPI (German Pharmaceutical Association) and is used by over one hundred professionals daily.