DIA Global Forum
Author: Darryl Clarke, Sciformix Corporation
It is clear that full eCTD implementation is set to have significant impact on the industry. The costs and regulatory operations expertise associated with the operational changes and new technologies required to remain compliant will be a chief concern for pharmaceutical companies across multiple geographies.
Looking forward, pharmaceutical companies should be preparing for electronic submissions and not wait until a final guidance is released. It should be a priority for all companies to have the appropriate systems in place, or to be working with a service company that meets their needs, so they are adopting a proactive approach to electronic submissions. This best practice model will ensure that organizations successfully achieve compliance with the regulatory requirements while increasing efficiency and reducing submission process costs.