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NDA Success Strategy: Using Non-US Clinical Data in an NDA Submission

Clinical Trial Regulations Strategic Consulting

When our sponsor acquired an investigational asset from an international company, they faced a critical regulatory challenge: Could clinical data from foreign trials not conducted under a U.S. IND be included in their New Drug Application? The foreign studies deviated from ICH E3 format and lacked U.S.-specific regulatory documentation.

Partnering closely with our sponsor, Veristat’s global regulatory affairs team applied its deep expertise in global regulatory strategy to maximize the value of foreign trial data for NDA inclusion. Our collaborative efforts led to successful FDA acceptance of foreign clinical studies and efficient NDA review that adhered to PDUFA goals.

👉 In this case study, learn how our regulatory team worked closely with our sponsor to solve challenges across numerous areas including:

  • Regulatory gap analysis

  • GCP compliance evaluation

  • ICH E3 mapping

  • Missing documentation remediation

  • FDA meeting support

  • Submission planning and authoring

Download our complete case study "NDA Success Strategy: Using Non-US Clinical Data in an NDA Submission"
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