Embase for Regulatory Affairs

Information for regulatory affairs professionals

With over 24 million indexed records and more than 7,500 current, mostly peer-reviewed journals and Articles In Press, Embase is a Product Literature Database (PLD) solution which meets the requirements of regulatory bodies concerned with the investigation of adverse drug reactions (ADRs) and their prevention. Embase also supports systematic reviews through its wider coverage, inclusion of Medline, frequent updates and deeper drug indexing for greater biomedical information coverage.

Embase for Regulatory Affairs Research

• Look up reported economic evaluations of specific drug therapies or disease management
• Compare the therapeutic effects of 2 or more substances on a disease
• Track a specific drug trade name or names in the literature
• To retrieve necessary information needed to comply with legislation and regulations
• Clinical trial program management, including protocol and study report writing
• PI/Supplementary Protection Certificates and IB writing
• Regulatory filing documentation such as New Drug Application (NDA)