To support the development of new drugs and biologics, the regulatory authorities publish and maintain a large body of knowledge. This information typically includes webpages, guidance documents, notices, regulations, and product labels. In addition, it often covers product-specific assessments and reviews, correspondence documents, milestone meeting minutes, advisory committee deliberations, information requests, letters, and more.

This level of support and transparency from the regulators is welcomed by the industry but it comes with significant challenges.

Cedience addresses these challenges, bridging knowledge gaps and equipping drug development teams with the information they need to support their decisions.

By automatically centralizing and integrating the regulators’ databases, our SaaS platform enables you to answer complex questions on precedents in minutes instead of days, and generate unique datasets that can augment your regulatory intelligence activities.

• There’s a large number of databases that need to be closely monitored for each regulatory agency of interest
• The databases are disconnected and the information within them is not standardized
• Datapoints of relevance are hidden within thousands of pages of information
• Datasets have to be collected and synthesized manually to support critical decisions.
• These challenges result in significant knowledge gaps in the industry.