BioInsights Team

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Our team has an average of 15+ years in diagnostics product development, regulatory affairs, clinical affairs, quality, and commercialization. We’ve successfully launched multiple tests and technologies and engaged with leading regulatory agencies and clinical societies.

We have successfully guided multiple laboratory-developed tests (LDTs), IVDs, and medical technologies from feasibility to market launch — including:

• Assay development and analytical validation
• Clinical validation study design and execution
• Regulatory submissions (CLIA, CAP, FDA, CMS)
• CPT and PLA Codes
• Quality system integration and manufacturing scale-up

We go beyond product development to ensure market adoption by supporting:

• Clinical utility evidence generation
• Coding and billing
• Society & guideline engagement strategies
• Reimbursement pathway design + payer evidence plans
• Go-to-market commercialization strategy

We simplify complex regulatory pathways by:

• Crafting clear regulatory strategies tailored to your product
• Preparing submission-ready documentation and dossiers
• Facilitating interactions with regulatory bodies (FDA, CAP, etc.)

Our structured project management approach ensures milestone discipline and cross-team alignment:

• Integrated project plans + risk trackers
• Defined decision points + escalation pathways
• Transparent reporting dashboards for all stakeholders