Navigate through market authorisations

Using the two integrated modules of the CDM Medical Regulatory Manager – an Advanced Product Database and a Regulatory Project Module – Actavis is radically optimising its way of managing market authorisations and regulatory submissions.

The Advanced Product Database combines a worldwide product hierarchy (eg, pharmaceutical products, brands, packings and indications) with information of company collaborators, and activities in a relational database structure. The solution provides an easy overview of the present status of all products and monitors regulatory data such as market authorisations, renewal and withdrawal dates, and occurrences. The built-in early warning systems measures whether deadlines are met and enables the Regulatory Department to react accordingly.

The Regulatory Project Module integrates with the Advanced Product Database and is optimised for regulatory affairs departments. Streamlining and measuring the effectiveness of regulatory submissions is enabled through project tracks – template lists of milestones, checkpoints, and activities. Project tracks can be defined in accordance with the relevant national or EU regulatory procedure.

Finally, the Integrated CRM Functionality links the approval of market authorisations and variations with marketing- and sales campaigns – and thus giving the sales and marketing managers the ability to launch their products or change message management strategy in synchronisation with the Regulatory Department.

For more information, please visit www.cdm.dk.