Lab Director Services

About Laboratory Director Services

Access experienced, board-certified, state-licensed HCLD laboratory director leadership to support scientific integrity, operational oversight, and compliance obligations. This service is designed for programs that need qualified director coverage, guidance on regulatory expectations, or strengthened governance across IVF and andrology laboratory operations.

Support can include director-level review of key processes, documentation expectations, quality and compliance alignment, and readiness planning for inspections or accreditation milestones. The coLABorative can help you navigate expectations across CLIA, CAP, Joint Commission, FDA, SART, and state-specific requirements, including states with enhanced oversight such as New York, New Jersey, California, and Florida.

This is a practical leadership service focused on keeping your lab compliant while supporting consistent, high-quality outcomes.

What this can cover

  • HCLD director access and leadership support
  • Compliance alignment across major frameworks and inspections
  • Policy and process governance support
  • Risk mitigation and readiness planning

The CoLABorative management team includes Dara Berger, PhD, MPH, MS; Charlene Alouf, PhD, HCLD, TS; Gerry Celia, MBA, PhD, HCLD, CC; and Liesl Nel-Themaat, PhD, HCLD, MBA.

Frequently Asked Questions

The coLABorative is a consulting and management company specializing in reproductive laboratory services. We provide comprehensive solutions for in vitro fertilization (IVF) programs, including laboratory design, construction, staffing, accreditation, and ongoing management services.

Our team brings over 60 years of combined experience in assisted reproductive
medicine. Each of our four partners holds a PhD, High Complexity Laboratory Director
(HCLD) certification, and three hold MBAs. We offer a unique multi-tiered service model
that allows us to support you at any stage from initial consultation to complete
laboratory ownership and management.

We work with independent reproductive endocrinologists and physician groups who
want to develop or enhance their laboratory capabilities. Our clients range from
established practices seeking modernization to physicians starting new IVF programs.

We provide a complete spectrum of laboratory solutions:

  •  Laboratory Audits: Comprehensive evaluations for quality assurance, regulatory compliance, or investor due diligence
  •  Design & Build Services: Custom laboratory design, equipment selection, and construction oversight
  • Accreditation Support: Guidance through regulatory requirements and accreditation processes
  •  Staffing Solutions: Recruitment assistance, training programs, and temporary staffing
  • Project Management: Turn-key operations for new laboratory development
  • Laboratory Management: Full-service ongoing management of laboratory operations
  • Consulting Services: Strategic planning, process optimization, and best practice implementation

No. We work with laboratories at all stages—from greenfield projects to established
facilities seeking modernization, expansion, or improved operational efficiency.

Absolutely. Our team has extensive experience navigating regulatory requirements and
securing accreditation from bodies such as the College of American Pathologists (CAP),
The Joint Commission, and state-specific licensing agencies.

Absolutely. Our team has extensive experience navigating regulatory requirements and
securing accreditation from bodies such as the College of American Pathologists (CAP),
The Joint Commission, and state-specific licensing agencies.

Our Team

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