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Blog

How the US FDA MIDD paired pilot program helps sponsors

February 28, 2025 For the past couple of decades, leading American institutions, pharmaceutical and biotechnology…

CertaraFebruary 28, 2025

White Paper

Rare Oncology Product Launch Playbook: Universal Strategies for Success in the U.S. and Europe

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CertaraFebruary 28, 2025

Webinar

Phoenix WinNonlin & PK Submit: Industry-Standard Software for Smarter PK/PD Workflows

CertaraFebruary 28, 2025

On-Demand Webinar

PBBM Educational Webinar Series (Part 1): The Basics of Drug Absorption in Drug Development – Why is Drug Absorption Essential? [Japanese Webinar]

Part 2 on July 17th : What is the Drug Absorption Model? Part 3 in…

CertaraFebruary 27, 2025

Fact Sheet

D360 Fact Sheet

CertaraFebruary 27, 2025

Publication

Combining mechanistic modeling with machine learning as a strategy to predict inflammatory bowel disease clinical scores

In this paper, we discuss a method to integrate simulated markers of inflammation from a…

CertaraFebruary 27, 2025

Video

Accelerating CMC Success in Rare Disease Drug Development

New drug approvals in rare diseases are rising, bringing hope to patients. But with accelerated…

CertaraFebruary 26, 2025

Video

Leveraging Real-World Evidence (RWE) in Rare Disease Drug Development

The path to regulatory approval and market access for rare disease therapies presents unique challenges.…

CertaraFebruary 26, 2025

Video

Bridging Global Health Disparities in Rare Disease Drug Development

Rare diseases know no borders—but access to life-changing treatments remains unequal across the world. In…

CertaraFebruary 26, 2025

Video

Advancing Rare Disease Therapies: The Power of Regulatory Expertise

Bringing treatments to patients with rare diseases has long been one of the biggest challenges…

CertaraFebruary 26, 2025

How the US FDA MIDD paired pilot program helps sponsors

Rare Oncology Product Launch Playbook: Universal Strategies for Success in the U.S. and Europe

Phoenix WinNonlin & PK Submit: Industry-Standard Software for Smarter PK/PD Workflows

PBBM Educational Webinar Series (Part 1): The Basics of Drug Absorption in Drug Development – Why is Drug Absorption Essential? [Japanese Webinar]

D360 Fact Sheet

Combining mechanistic modeling with machine learning as a strategy to predict inflammatory bowel disease clinical scores

Accelerating CMC Success in Rare Disease Drug Development

Leveraging Real-World Evidence (RWE) in Rare Disease Drug Development

Bridging Global Health Disparities in Rare Disease Drug Development

Advancing Rare Disease Therapies: The Power of Regulatory Expertise

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