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Project Optimus Resource Portal

With the evolving regulatory landscape in oncology, we know that it is critical to stay on top of the latest news and be informed. We are continuously developing and curating up-to-date content on Project Optimus to help you understand the changes and implications for your oncology programs.

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Let’s advance oncology drug development together

Certara’s integrated team of oncology experts is ready to guide your program through FDA Project Optimus. With tailored solutions, advanced modeling techniques, and regulatory expertise, we help you achieve your drug development goals efficiently.

Proven track record in oncology drug approvals
Industry-leading Simcyp Simulator technology
Expertise spanning early development to regulatory submissions