With an ever-increasing regulatory landscape, it is important to know what is coming next. Looking into regulatory ...

While the opinions about the information model for Regulatory Information Management vary and are subject to many ...

As one of the last actions in 2016 (effective December 17, 2016) the FDA enforced some new criteria that will allow ...

…is a frequently asked question in the regulatory industry. The legislative EU deadline, 1st of July 2016, has kicked ...

Digital transformation is a hot topic. When applied to health products development, being able to combine science and ...

A revision of the Swiss eCTD Module 1 Specification documentation has been officially published by Swissmedic (link ...