Rare Oncology Product Launch Playbook: Universal Strategies for Success in the U.S. and Europe White Paper Rare Oncology Product Launch Playbook: Universal Strategies for Success in the U.S. and Europe Lorem ipsum dolor sit amet consectetur. At venenatis urna sapien ut lorem enim. Morbi lectus…CertaraFebruary 28, 2025
Accelerating CMC Success in Rare Disease Drug Development 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
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Advancing Rare Disease Therapies: The Power of Regulatory Expertise 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 Biosimulation is Transforming Rare Disease Drug Development Video How Biosimulation is Transforming Rare Disease Drug Development Developing therapeutics for rare diseases comes with unique challenges—small patient populations, high variability in treatment…CertaraFebruary 26, 2025
Gene Therapy: A Transformative Shift in Rare Disease Treatment Video Gene Therapy: A Transformative Shift in Rare Disease Treatment After decades of promise, gene therapy is finally starting to deliver on its potential—especially for…CertaraFebruary 26, 2025
Navigating Rare Disease Regulations: Challenges, Opportunities, and Innovative Solutions Video Navigating Rare Disease Regulations: Challenges, Opportunities, and Innovative Solutions Bringing life-changing therapies to rare disease patients requires expertise, innovation, and a deep understanding of…CertaraFebruary 26, 2025
The Tools You Need to Accelerate Rare Disease Drug Development Fact Sheet The Tools You Need to Accelerate Rare Disease Drug Development CertaraFebruary 20, 2025
Why FDA’s omaveloxolone approval for Friedreich’s ataxia matters Blog Why FDA’s omaveloxolone approval for Friedreich’s ataxia matters January 10, 2025 Friedreich’s Ataxia (FA) is a rare, genetic, and progressive neurodegenerative disorder. A…CertaraJanuary 10, 2025