Laboratory Buildout & Launch Services

TaliaGen provides comprehensive end-to-end laboratory buildout support, guiding organizations from initial planning through full operational launch. Our team partners with you to design, implement, and scale a laboratory infrastructure that aligns with your intended test offerings, regulatory requirements, and long-term growth strategy.

We offer expert guidance on laboratory space planning, layout, and infrastructure, ensuring your facility is optimized for workflow efficiency, compliance, and future expansion. In parallel, we assist with the preparation and submission of required CLIA certification and accreditation documentation, streamlining the path to regulatory approval.

Operational Oversight & Laboratory Management

Our services extend beyond physical buildout to include hands-on operational oversight and management, ensuring your laboratory is compliant, efficient, and inspection-ready from day one.

Key areas of support include:

  • Personnel Recruitment & Training
    Recruitment, onboarding, and training of qualified laboratory personnel across all phases of testing.

  • Quality Management Systems (QMS)
    Development, implementation, and maintenance of a robust quality management program aligned with CLIA, CAP, and COLA standards.

  • Scientific & Clinical Oversight
    Direct oversight of scientific operations and clinical testing activities to ensure analytical integrity and regulatory compliance.

  • SOP & Policy Development
    Drafting and implementation of general and technical CLIA-compliant Standard Operating Procedures (SOPs) and laboratory policies.

  • End-to-End Test Development & Launch
    Comprehensive support for assay buildout, validation coordination, workflow design, and test launch readiness.

  • Laboratory Information Systems (LIS/LIMS)
    Guidance on selection, implementation, and onboarding of laboratory information and management systems tailored to your testing model.

  • Capital Equipment & Vendor Support
    Assistance with capital and ancillary equipment selection, purchasing strategy, and vendor relationship management..

Our Approach

TaliaGen combines regulatory expertise, operational insight, and real-world laboratory experience to help laboratories launch efficiently, operate confidently, and scale successfully, without unnecessary delays or compliance risk.