Optimizing the Regulatory Strategy for a New Anti-cancer Drug

This small US biotech company needed to develop integrated clinical pharmacology and regulatory arguments to support their first new drug application (NDA) filing for a novel targeted anti-cancer drug. A team of Certara scientists performed a clinical pharmacology NDA gap analysis, which then informed strategic positions for the NDA submission. Read this case study to learn how the gap analysis provided the sponsor with a risk assessment for the gaps in the data package, which allowed them to prepare for potential review cycle information requests and post-marketing requirements/commitments.

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