Leo Pharma selects new regulatory affairs management system

Leo Pharma is to deploy a new regulatory affairs management system from Aris Global in order to improve the efficiency of its drug development programmes.

The Register system is utilised by several leading pharmaceutical companies and will allow Leo Pharma to manage and track the worldwide registration processes of drugs across their entire life cycles.

Via a single integrated and automated regulatory submission system, the firm can examine country and company-specific registration data, both on a local and global level.

Nina Christiansen, director of corporate regulatory affairs at Leo Pharma, said this will improve compliance with regulatory requirements, enhance efficiency and reduce the risk of oversights.

"This strategic project is of great importance to Leo Pharma to enable regulatory affairs to share information and plans in our global organisation and with our internal stakeholders," she added.

Earlier this month, the company published positive new clinical data on its actinic keratosis treatment ingenol mebutate gel, which will be used to support submissions for approval of the drug.