From Molecular Discovery to Clinical Laboratory Implementation

Biotech Insight Solutions helps biotechnology companies, research organizations, and clinical laboratories move promising molecular assays from discovery into documented, validated, and sustainable testing workflows.

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About

Biotech Insight Solutions provides specialized scientific and technical consulting to molecular diagnostic laboratories, biotechnology companies, and research organizations translating promising assays into clinical use.

We help clients plan and implement molecular testing workflows, develop LDT validation strategies and documentation, prepare SOPs and quality systems, review NGS and bioinformatics processes, and assess laboratory inspection readiness.

Founded by David Cheishvili, PhD, the firm brings more than 25 years of experience in molecular biology, epigenetics, cancer biomarkers, clinical NGS, bioinformatics, assay development, and translational diagnostics.

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CLEAR DELIVERABLES FOR YOUR LAB

Each engagement is structured around defined outputs that your laboratory can review, implement, and maintain.

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Assessment & planning
Gap assessment & roadmap
Written gap assessment with prioritized corrective actions.
Validation & documentation
Validation and SOP package
Validation plans, protocols, acceptance criteria, and SOPs.
Workflow & readiness
Operational readiness review
Workflow diagrams, QC/QA plan, and readiness checklist.

Services

Biotech Insight Solutions provides focused scientific and technical support for laboratories and biotechnology teams moving molecular assays from development into operational testing.

Laboratory Development & Implementation

New laboratory startup, molecular workflow development, test implementation, SOP preparation, quality-system development, and pre-inspection readiness assessment.

LDT Validation & Documentation

Validation master planning, assay protocols, acceptance criteria, analytical performance studies, troubleshooting, and technical documentation.

NGS & Bioinformatics Assessment

Sequencing workflow and QC review, bioinformatics pipeline assessment, DNA methylation analysis strategy, and data-to-result interpretation.

FOUNDER EXPERTISE

Review the scientific and technical background behind Biotech Insight Solutions, including more than 25 years of experience in molecular diagnostics, epigenetics, assay development, clinical validation, bioinformatics, and laboratory quality systems.

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NEED CLINICAL LAB CONSULTING SUPPORT?


If your laboratory or biotechnology team needs support with molecular assay implementation, LDT validation, SOPs, quality systems, NGS workflows, bioinformatics review, or inspection readiness, let’s discuss the project.

REQUEST A CONSULTATION
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