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