Confidence Beyond Compliance

During the maintenance phase of the product life-cycle, changes to an approved dossier might occur for a variety of reasons. All dossier information is considered part of the Marketing Authorization, and therefore any changes made to an approved dossier have to be notified respective health authorities before a change can be implemented. Not all changes have the same impact when implemented, so they have to be classified according to the possible effect they might have on the authorized product. There are different classification guidelines in place in different countries.

PharmaLex helps clients to determine the classification of quality changes, variation applications and guides clients throughout the entire change process.