At Flagship Biosciences, we help drive biomarker development strategies from early discovery through commercialization. Our team works closely with clients to navigate the regulatory landscape efficiently and effectively, aligning assay development with FDA and global requirements to support successful clinical trials and companion diagnostic (CDx) approval.

We offer end-to-end support—from initial planning to regulatory submission—acting as a collaborative partner throughout the process. With experience interfacing directly with the FDA, we guide you through each phase with clarity and confidence.

What You Can Expect

We start by conducting a gap analysis of your existing data and documentation to identify what’s needed to meet regulatory expectations. From there, we develop a tailored roadmap to move your biomarker assay toward approval, which may include:

• Timelines and strategies for assay development and analytical validation
• Plans for prospective and retrospective biomarker studies
• Recommendations for LDT development and cutoff determination
• Regulatory submission planning, formatting, and communication strategies
• High-level value assessment across clinical, lab, and payer perspectives

Throughout, we integrate seamlessly into your development program—delivering strategic, scientific, and operational support to accelerate progress while ensuring compliance.

From discovery to approval, Flagship is your partner in advancing precision diagnostics.

At Flagship Biosciences, we help drive biomarker development strategies from early discovery through commercialization. Our team works closely with clients to navigate the regulatory landscape efficiently and effectively, aligning assay development with FDA and global requirements to support successful clinical trials and companion diagnostic (CDx) approval.

We offer end-to-end support—from initial planning to regulatory submission—acting as a collaborative partner throughout the process. With experience interfacing directly with the FDA, we guide you through each phase with clarity and confidence.

What You Can Expect

We start by conducting a gap analysis of your existing data and documentation to identify what’s needed to meet regulatory expectations. From there, we develop a tailored roadmap to move your biomarker assay toward approval, which may include:

• Timelines and strategies for assay development and analytical validation
• Plans for prospective and retrospective biomarker studies
• Recommendations for LDT development and cutoff determination
• Regulatory submission planning, formatting, and communication strategies
• High-level value assessment across clinical, lab, and payer perspectives

Throughout, we integrate seamlessly into your development program—delivering strategic, scientific, and operational support to accelerate progress while ensuring compliance.

From discovery to approval, Flagship is your partner in advancing precision diagnostics.