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WHITE PAPER

DSURs, RMPs, and PSURs – The Harmonization of Pharmacovigilance Documents

Are complex pharmacovigilance documents slowing down your drug development?

Pharmacovigilance is critical for ensuring drug safety, but navigating the maze of regulatory requirements can be daunting. Our comprehensive white paper, authored by Certara’s leading experts, reveals how harmonizing Development Safety Update Reports (DSURs), Risk Management Plans (RMPs), and Periodic Safety Update Reports (PSURs) can transform your pharmacovigilance efforts.

What you’ll learn

Integrated safety reporting: Streamline monitoring by harmonizing DSURs, RMPs, and PSURs

Regulatory excellence: Align with global regulations and avoid compliance pitfalls

Risk mitigation: Proactively identify and manage safety concerns with consistent data collection

Process optimization: Reduce complexity and boost reporting efficiency

Strategic insights: Leverage safety data for informed clinical and regulatory decisions

You’ll be equipped to:

Meet regulatory timelines with confidence
Significantly reduce resource expenditure
Accelerate your drug development timeline
Make data-driven decisions to enhance drug safety

Timely and relevant

Regulatory bodies worldwide are increasingly emphasizing harmonized documents. Stay ahead of the curve!

Download the white paper

Simply fill out the form and download the white paper for free!

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.