Use our interactive assessment to get a personalized readiness score. See how your Model-Informed Drug Development (MIDD) strategy aligns with the latest ICH M15 guidance, FDA expectations, and EMA requirements.
ICH M15 Interactive Scorecard
Are you ready for the ICH M15 guideline?
Assess your ICH M15 readiness in minutes
Identify gaps, strengthen model credibility, and align your MIDD strategy with global regulatory expectations.
Why use our free interactive scorecard app?
Interactive Benchmarking
Complete the assessment in under 5 minutes, anytime on desktop or mobile, to see where you stand.
Identify Critical Gaps
Pinpoint specific alignment risks before your next regulatory submission.
Instant PDF Scorecard
Receive a comprehensive, presentation-ready report of your results.
Drive Team Action
Easily share your PDF report to align internal stakeholders on clear next steps.
What you'll assess
Evaluate your readiness across key ICH M15 areas:
Model credibility and risk-based frameworks
Cross-functional alignment
Regulatory interaction planning
Global submission readiness (FDA, EMA, PMDA)
Real-world application of MIDD
Start your ICH M15 readiness assessment
Complete the form to access the interactive app, get your ICH M15 readiness score & PDF report.
The Certara ICH M15 scorecard
About Certara
Certara is dedicated to transforming drug discovery and development for good. We harness the power of biosimulation, advanced analytics, and regulatory expertise to create a future where treatments reach patients faster and more efficiently.
From discovery to market access and commercial, we tailor solutions to meet our clients’ most pressing challenges. Through strategic leadership and advanced predictive technologies, Certara provides comprehensive solutions to optimize drug development processes, reduce risks, and improve outcomes. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.
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