RegChange is an application for regulatory professionals and employees of the pharmaceutical industry involved in change control processes. With a few clicks, the app classifies an intended change according to EU guidance. The main content is the so-called “Classification Guideline” which gives guidance on the details of the various categories of variations based on the Commission Regulation (EC) No 1234/2008.
Advantages over the printed version of the Guideline are:
1. Simple navigation through the guideline, all conditions and documentation requirements at a glance.
2. Variation classification in a pocket. Answer all classification questions on the spot whether in the coffee corner or in a meeting.
3. Fully indexed change descriptions. A single keyword lists all relevant changes containing the keyword. Keyword search includes common synonyms. CMDh recommendations for classification of unforeseen variations (“Article 5”, “Z-Variations”) included.
4. Regular updates
5. Links to all relevant guidelines and frequently asked questions. Link-out of classified changes to Xendo’s fee calculator for a quick cost estimation.