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 a TAP portfolio
You have a NY permit and need to add more approved tests. We handle TAP 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.
NY CLEP
Full NY CLEP application + 5 TAP submissions + inspection prep
6–10 weeksstarting at $50,000 flatInspection-readiness audit
4 weeks$15,000 flatPre-TAP submission gap analysis
2 weeks$5,000 flatPer-LDT TAP submission
4–8 weeks$10,000 per testPost-rejection TAP rescue
6 weeks$20,000 flat
QMS
Full QMS build (new lab, going to CAP first time)
8–16 weeksstarting at $30,000 flatQMS fine-tune (existing QMS, CAP/CLEP polish)
4–6 weeks$15,000 flatCAP inspection readiness
8 weeks$15,000 flatCLIA high-complexity certification application
6 weeks$10,000 flat
Advisory
Monthly retainer (compliance officer-equivalent)
ongoing$5,000 / month
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.
AI-pathology specialty
Most consultants don't understand the NY CLEP digital-pathology route or the new FDA LDT rule. We do. Our team has published on this.
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.
Or email ahmed@tryesencia.com directly.