Guides, templates, and best practices for pharmaceutical regulatory affairs professionals. Everything you need to stay current with FDA, EMA, and Health Canada updates.
Step-by-step guide to tracking FDA Center for Drug Evaluation and Research updates, including guidance documents, approval letters, and safety alerts.
Download Guide →Track important EMA deadlines, CHMP meeting schedules, and guidance publication dates with our comprehensive calendar.
Download Guide →Essential checklist for preparing Health Canada drug submissions, including required documentation and common pitfalls to avoid.
Download Guide →Excel template for creating your own regulatory update tracking dashboard. Track sources, deadlines, and actions.
Download Guide →Comprehensive list of therapeutic areas and regulatory focus areas to help you filter and organize regulatory updates.
Read More →How to leverage AI tools for regulatory monitoring, including prompt engineering for summaries and alert optimization.
Read More →Center for Drug Evaluation and Research - FDA division responsible for evaluating small molecule drugs before they can be sold.
Center for Biologics Evaluation and Research - FDA division responsible for biologics including vaccines, blood products, and cellular therapies.
Committee for Medicinal Products for Human Use - EMA's scientific committee responsible for recommendations on medicine approvals.
Biologics License Application - Application required to market a biologic product in the United States.
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