Services and products

Find the right starting point.

Choose a defined project, ongoing support, or local software. Each offer below says who it is for, what you receive, and its starting price. We confirm scope, timing, and final fees in writing before work begins.

01 / LABORATORY PROJECTS

Get a study or launch over the line.

Technical review, validation, QC and launch documentation for a defined assay or problem.

Expert Report Review

From $375

For: A second opinion on one study or report

You receive: A findings memo with prioritized corrections and one revision round.

Vendor Rescue Sprint

From $2,500

For: A stalled instrument or assay launch

You receive: An evidence log, ranked resolution plan, and decision handoff.

Assay Launch Partner

From $8,500

For: An assay rollout from plan to handoff

You receive: Defined studies, QC setup, organized evidence, and go-live readiness documentation.

02 / COST AND OPERATIONS

Find avoidable cost without weakening quality.

We document the current process, estimate opportunities with stated assumptions, and give leaders a practical way to test improvements. Savings are not guaranteed.

Reagent Waste and Inventory Review

Custom quote

For: A laboratory with expired stock, frequent repeats or urgent orders

You receive: A reagent and repeat-cost baseline, stock and ordering recommendations, and a prioritized improvement plan with savings assumptions and quality measures.

Staffing and Workload Assessment

Custom quote

For: A team facing uneven workload, overtime or coverage gaps

You receive: Hourly workload and coverage analysis, accounting for test mix, QC, maintenance, training and turnaround time, plus scheduling options and a pilot measurement plan.

Analyzer Selection and Replacement Review

Custom quote

For: A planned instrument purchase, lease renewal or replacement

You receive: A vendor comparison, total operating-cost scenarios, capacity and service review, implementation requirements, and an executive decision memo with documented assumptions.

Send-Out vs In-House Testing Review

Custom quote

For: A test menu decision involving referral cost or turnaround time

You receive: Volume and cost scenarios, break-even estimates where supported, staffing and quality requirements, and a recommendation for leadership. Financial feasibility does not establish clinical suitability.

Laboratory Cost and Quality Review

From $5,000

For: One lab or defined process

You receive: A cost and workflow baseline, ranked opportunities, and an implementation plan.

2027 Laboratory Financial Impact Review

From $5,000

For: A defined laboratory test menu and payer model

You receive: Payment-exposure scenarios, cost and quality baseline, prioritized actions, and an executive decision memo.

Enterprise Opportunity Assessment

From $25,000

For: A defined cross-department pilot

You receive: Executive priorities, validation workshops, and a phased plan with owners.

03 / ONGOING AND SPECIALIST

Keep quality work moving.

Use a monthly plan for recurring work or scope specialized regulatory and international projects.

Managed Validation Plan

From $1,500/month

For: A recurring validation workload

You receive: Monthly project review, controlled tools and templates, office hours, and leadership summaries.

Quality Partner

From $2,500/month

For: Defined single-laboratory quality and readiness support

You receive: Evidence map, scoped review queue, corrective-action follow-up, and monthly director reporting. Setup and backlog cleanup are quoted separately.

Corporate Laboratory Support Program

Pilot from $25,000

For: Health systems and laboratory networks

You receive: One organizational framework, defined participating sites, local work plans, and consolidated executive reporting. Ongoing coverage is custom quoted.

Licensing and Renewal Support

Custom quote

For: CLIA, state, or accreditation paperwork

You receive: A requirement checklist, draft package, deadline tracker, and agency follow-up log.

Global Diagnostics Support

Custom quote

For: International labs and IVD teams

You receive: A scoped study or evidence plan for quality systems, analytical performance, or market readiness.

04 / QUALITY SYSTEMS

Make recurring quality work easier to manage.

Defined consulting projects with practical deliverables. We confirm requirements, jurisdiction, specialist needs and the laboratory’s decision owners during scoping. These services do not imply a live tracking portal or accreditation authority.

Competency and Personnel Documentation Review

Custom quote

For: A laboratory preparing staff evidence for leadership review

You receive: A role and test-system matrix, record-gap register, assessment schedule and responsibility handoff. Authorized laboratory personnel perform and approve competency assessments.

SOP and Document Control Setup

Custom quote

For: Teams managing inconsistent versions or overdue document reviews

You receive: A document inventory, version and approval workflow, review calendar and prioritized SOP revision plan for your team’s approval.

Test Menu and Quality Coverage Review

Custom quote

For: A growing test menu or multiple laboratory locations

You receive: A documented review of test ownership, method records, applicable PT or alternative assessment coverage, and renewal responsibilities, with source references and unresolved items for leadership.

Corrective Action and Effectiveness Review

Custom quote

For: A completed survey finding or a released quality-event evaluation

You receive: An evidence-based cause review, draft action plan, owners, due dates and follow-up measures. PT support covers enrollment/process review and permitted post-event evaluation, never answers or analysis for an active PT challenge.

Browse guidance and preparation resources →

05 / SOFTWARE

Generate structured reports in your own lab.

Explore the public demonstration, then discuss a private-pilot installation for Windows or macOS. Pilot scope and supported workflows are agreed before installation. The demo is not a production report service.

AssayIQ Local Lab Edition

License from $7,500

For: Labs that want to pilot a local validation reporting workflow

Proposed scope: A locally installed application and reporting workflow, subject to pilot agreement. Installation starts at $2,500; maintenance starts at $1,800/year in year two.

Custom Instrument Build

From $15,000

For: An instrument or assay menu outside the standard offering

Proposed scope: A custom local application and reporting workflow, defined and tested during the project. Implementation starts at $3,500; maintenance from $3,000/year.

ADDITIONAL CAPABILITIES

Need a different scope?

We also support proficiency testing and interference investigations, inspection readiness, infection prevention, training and SOPs, laboratory startup, and analyzer or LIS planning. Tell us the decision you need to make and the evidence you already have.

Describe your project

Start with a clear scope.

We agree on inputs, deliverables, decision owners, review limits, and timing. Clinical and regulatory approval remains with the client's authorized leaders.

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