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...more

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.less