Regulatory and compliance for clinical labs.
NY CLEP. CAP. CLIA. QMS. Built by the team that took the first AI-pathology assay through New York State with zero deficiencies. Fixed scope, fixed price, no hourly surprises.
Four kinds of labs we partner with most.
Labs going to New York for the first time
You're CAP-accredited and ready to report results to NY residents. We get you NY State-permitted and through your first Test Approval Program submissions in 6–10 weeks.
Labs scaling an LDT portfolio
You have a NY permit and need to add more approved tests. We handle LDT submissions end-to-end at fixed price per test.
New labs building toward CAP for the first time
You're standing up a clinical laboratory from scratch. We build the QMS, write the SOPs, and prep you for your first CAP inspection.
AI diagnostic startups
You're commercializing an AI medical device. We map your FDA pathway, CLIA/CAP/NY CLEP requirements, and reimbursement strategy in one engagement.
Fixed scope, fixed price. No hourly surprises.
Every engagement is a written, fixed-scope proposal. Tap any row to see what's included — or skip ahead and request a quote.
Engagements include a kickoff call, all deliverables in writing, and revisions until accepted by the relevant regulatory body. Larger or non-standard scopes priced on request.
Three steps from first call to kickoff.
Discovery call (30 min)
Tell us your lab, your current status, and your target. We tell you which engagement fits.
Fixed-scope proposal (within 48 hours)
Written proposal: scope, deliverables, timeline, price. No hourly ranges. No expanding fees.
Kickoff (within 1–2 weeks)
We start. Weekly status, written deliverables, fixed milestones.
Operators, not consultants.
Operator-grade expertise
Our regulatory lead came out of a clinical laboratory where he personally took an AI pathology assay through FDA Breakthrough, CAP, and NY CLEP with zero deficiencies. Operating experience, not consulting theater.
Fixed price, fixed scope
White-shoe firms charge $75k–$150k for NY CLEP. We charge less, deliver faster, and never hand you a surprise bill.
2-week turnaround on gap analyses
We don't bill for slowness.
Tell us where your lab is and where you want to be.
30-min discovery call. Fixed-scope proposal in 48 hours afterward.