Variations and renewals


Variations are all the changes made in the dossier of an authorised product after its initial registration. They may concern administrative changes, Quality changes, Safety/Efficacy changes or Vigilance changes. Irrespective of the variation, we are fully capable of preparing the necessary documents for a successful application for variation.

Renewals are important in order to ensure that the lifecycle of a product continues. Marketing authorisations are usually valid for five years before they need a renewal. If your marketing authorisation is expiring we have the ability to provide expertise on prolonging the life of your product.