Your Partner for Developing Laboratory Developed Tests (LDTs)

Empowering Precision Medicine with Expert Consulting Services

Our LDT Consulting Services

Celegence specializes in providing expert consulting services for organizations interested in developing Laboratory Developed Tests (LDTs). Our consulting team offers comprehensive support and guidance throughout the development process, ensuring compliance with regulatory standards and delivering accurate and reliable diagnostic solutions.

Need Help with FDA LDT?

Why Choose Celegence for Your LDT Development Needs?

Regulatory Guidance

Celegence provides comprehensive guidance on FDA and CLIA standards, ensuring compliance and reliability in LDT development

Strategic Planning

We help clients develop strategic plans for LDT development, ensuring alignment with their overall healthcare objectives

Technical Expertise

Our team of experienced professionals offers technical expertise in LDT development, from assay design to validation

Market Analysis

We conduct thorough market analysis to identify opportunities and challenges in the LDT market, guiding clients towards successful product launches

Celegence is committed to innovation, constantly exploring new technologies to enhance our consulting capabilities and provide advanced solutions for our clients.

LDT Timeline

Stage 1

By May 6, 2025, labs must update their QMS to include adverse event reporting, corrections and removals reporting, and complaint file maintenance.

Stage 2
By May 6, 2026, labs must complete registration and device listing for their LDT, and update QMS to include labeling and investigational use requirements.
Stage 3
By May 6, 2027, labs must update their QMS to meet remaining FDA Medical Device requirements, including design controls, purchasing controls, acceptance activities, CAPAs, and records.
Final Stage
Depending on the LDT’s risk classification, it must be submitted to the FDA by November 6, 2027, for PMA submissions or by November 6, 2028, for 510k or De Novo pathways.

Benefits of Partnering with Celegence

  • Efficiency: Our streamlined processes and experienced team ensure efficient LDT development timelines.
  • Quality Assurance: We uphold the highest standards of quality assurance, guaranteeing reliable and accurate diagnostic solutions.
  • Cost-Effectiveness: Our consulting services are designed to be cost-effective, helping clients achieve their goals within budget constraints.

Join leading healthcare providers who trust Celegence as their preferred consulting partner for Laboratory Developed Tests.

Additional Information

Download the latest brochure of our capabilities and services.

DOWNLOAD PHARMACEUTICAL BROCHURE
Pharmaceutical Industry Regulatory Affairs - Celegence
Contact Us Today

From strategic planning to regulatory guidance, Celegence is your trusted partner for Laboratory Developed Tests (LDTs). Contact us today to learn how we can support your LDT development efficiently and cost-effectively.

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