Leveraging extensive regulatory knowledge to develop the most effective biomarker development strategies

Flagship’s regulatory team drives biomarker development strategies at all stages of the approval process. We establish a development partnership with your team from early discovery through commercialization. Our deep understanding of the regulatory standards and pathways ensures concise, stepwise regulatory development in a time and cost-efficient manner. Our team will seamlessly integrate with your development plans to serve as a partner through the entire process.

We have a successful track record working directly with the agency to ensure your therapeutic success.

Comprehensive multi-dimensional drug development expertise

  • Biomarker development strategy and regulatory pathways
  • CDx planning and regulatory development
  • Data review and analysis
  • Regulatory meetings and interface with FDA
  • Commercialization support
  • Regulatory submissions and maintenance:
    • Pre-submission background information packages
    • Pre-IDE and IDE filings
    • Pre-IND submissions and materials
    • Preparation of IND files

Our Process