Stay current with the ever-changing Pharma regulatory landscape
Speak to our teamStreamline cross-team collaboration and ensure compliance along the drug life cycle to increase your chances of positive regulatory outcomes.
Enable all biopharma regulatory and compliance teams to easily track changing legislation and monitor drug safety risks with high-quality, comprehensive regulatory, pharmacovigilance and CMC intelligence. Overcome the challenges of identifying and monitoring the latest guidelines and empower your teams to focus on setting your therapies up for regulatory success.
Identify and anticipate toxicity and safety events commonly seen in your drug class and benchmark the safety profile of competitor compounds.
Monitor regulatory concerns and assess label information from FDA, EMA and PMDA to anticipate potential contingencies based on the assessment of similar therapies.
Optimize risk management planning with an integrated view of FAERS, JADER and other manually curated safety data to identify and assess potential pharmacovigilance signals.