Roadmap from drug discovery through regulatory approval
Regulatory intelligence, compliance & monitoring
- Quickly understand regulatory requirements across all aspects of therapy development
- Prepare for inspections, understand trends in drug approvals and discern submission requirements and instructions
- Conduct pre- and post-marketing surveillance and understand approvals
Safety & toxicology intelligence
- 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.
HTA intelligence
- Confidently prepare HTA submissions and evidence dossiers
- Understand clinical drivers of positive HTA decisions and plan for Phase II and Phase III trials
- Benchmark HTA agency timelines and track competitors’ access in HTA-regulated markets
