Laboratory Compliance & Development

The science is
rarely the
hard part.

Phoenix Laboratory Consulting provides expert guidance in laboratory development, regulatory compliance, NYSDOH licensure, and CAP accreditation — from concept through launch.

Explore Services NYSDOH Compliance System →
20
Years of expertise in pharmacogenomics & molecular diagnostics
PGx
Translating complex pharmacogenetic results into accurate, actionable clinical calls
Full‑spectrum
From concept and launch through remediation, compliance, and long-term laboratory success
Bronwyn Ramey

About

Bronwyn Ramey, PhD, MB(ASCP), CGMBS, HCLD(ABB)
Founder & Principal Consultant

Bronwyn Ramey is a pharmacogenomics leader with over two decades of experience building, directing, and transforming clinical molecular diagnostic laboratories. She founded Phoenix Laboratory Consulting in 2014 after a career that took her from postdoctoral pharmacogenetics research through senior laboratory director and program leadership roles at organizations including OneOme, GeneDx, and LetsGetChecked.

Her work spans the full laboratory lifecycle — from concept through launch, and from remediation through long-term regulatory compliance. She has launched pharmacogenomics programs at more than a dozen independent and hospital-affiliated locations, achieved and maintained CAP accreditation at organizations of all sizes, and designed workflows that scaled test volumes from hundreds to tens of thousands of samples annually while maintaining turnaround times under three days and failure rates below five percent.

Bronwyn holds a PhD in Microbiology and Biochemistry from Indiana University and completed postdoctoral fellowships in microbial pathogenesis at the University of Iowa and in pharmacogenetics at PGXL Laboratories. She is a New York State-certified pharmacogenomics laboratory director and holds certifications from ASCP, AAB, and the California Department of Health.

She serves as Chair of the Evidentiary Standards Committee for the STRIPE Collaborative Community, as an assessor for the European Molecular Genetics Quality Network (EMQN), and as a member of the PharmVar CYP2D6 and CYP3A Expert Committees.

Pharmacogenomics & Molecular Diagnostics
20+ years of specialized field experience
CYP2D6 & PGx Result Interpretation
Recognized expertise in complex pharmacogenetic calls
NYSDOH CLEP & CAP Regulatory Expert
Licensure, accreditation, test approvals & inspections
Full-spectrum Laboratory Services
Concept through launch, remediation & ongoing compliance

Services

What we do

Phoenix Laboratory Consulting guides laboratories through every phase of development — from initial concept and assay design through validation, regulatory approval, and operational launch. We break the development process into distinct phases so you can customize the program to your needs.

01
Assay Development
The ability to quickly design and deploy high-quality assays is a core competency of successful labs. We will never sacrifice quality for speed — but our experience helps you avoid mistakes that delay deployment. You get to better, faster.
Phase 1: Feasibility — needs assessment, regulatory review, cost projection & timeline
Phase 2: Design & Optimization — assay menus, technology acquisition, iterative testing
Phase 3: Clinical Validation — analytical performance, clinical utility, QA & reporting
02
Device Validation
Getting a new device or process into clinical use is difficult and time-consuming. We design and supervise functional, clinical, and analytical validations of molecular devices and processes — with an eye to both CAP accreditation and New York licensure. We oversee your staff, training them and helping prevent errors that waste time and money.
03
NYSDOH Licensure & Permitting
Expert guidance through New York State licensure, permit applications, and CLEP requirements — structured to minimize deficiencies and accelerate approval timelines.
04
Test Approval & Submissions
Preparation and submission of LDT approvals and test modification packets. Scientific and regulatory documentation that gets your technology investment into productive clinical use.
05
CAP Accreditation
Guidance through the College of American Pathologists accreditation process — from gap assessment and policy development through checklist preparation and mock inspections. Ensuring your laboratory meets CAP standards for quality, compliance, and patient safety.
06
PGx Result Interpretation
Recognized expertise in translating complex pharmacogenetic laboratory results into accurate clinical calls, with particular depth in CYP2D6. Consulting support for labs seeking interpretive guidance on challenging cases.
07
Inspection Preparation
Systematic readiness planning for both CAP and NYSDOH CLEP inspections. Deficiency-prevention frameworks, mock inspections, staff preparation, and documentation review — so your team walks into inspection day with confidence.
08
Due Diligence Inspections
Independent laboratory assessments for acquisitions, partnerships, or internal quality reviews. Objective evaluation of compliance posture, operational quality, and regulatory risk — giving stakeholders the information they need to make informed decisions.

Featured Product

NYSDOH CLEP
Compliance System

NYSDOH CLEP requirements are detailed and fragmented across multiple documents — easy to mismanage without a coordinated framework. This system consolidates twenty years of consulting experience into a structured implementation resource for laboratories that want to run CLEP preparation like a regulatory project.

The system includes
Designed for laboratories that want to
Licensing options
Single-Laboratory License
Full system access for one laboratory — ideal for labs managing their own NYSDOH compliance process.
Implementation Bundle
System access plus consulting support for guided, hands-on implementation.
Consultant Deployment Model
Designed for independent laboratory consultants to deploy across client engagements.
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Testimonials

What clients say

Phoenix Laboratory Consulting has helped laboratories across the country launch, validate, and grow — from concept through regulatory approval and beyond.

“

There once was a physician-owned lab whose business manager came quickly to the realization that he was totally clueless on how to start up a pharmacogenetics offering. In jumps consultant Bronwyn, head first, into the project. Mere days later that same business manager felt that the project was in complete control and headed towards best-in-class status. Three years later, having successfully launched within both time and capital budgets and having subsequently processed thousands of PGx samples, this same business manager is here to enthusiastically write a testimonial. We could not have lifted off of ground zero without the ‘from A to Z’ help contributed by Bronwyn to our scientists and staff members. I cannot say enough about her level of professionalism and depth of knowledge!

Taylor Fyfe
Business Manager, Advanced Pain Care Laboratory — Austin, TX
“

PGx testing is a tricky market right now. The path is unclear and the decisions that have to be made put a lot of capital at risk. Phoenix Lab Consultants helped guide us to the technology that best served our business model and projected growth. I won’t say we couldn’t have done it without Bronwyn, because we could have. It just would have cost a lot more money and time — and I’m not at all confident the outcome would have been as good.

Director of Laboratory Marketing
Louisville, KY
“

I love the relationship-centric approach you have to business. You keep your ears on the ground for industry relationship-building opportunities. You put us in touch with folks with which you see that there could be developed a possible synergistic or complementary relationship.

Clinic Manager
Client
“

You need to know that you are a good teacher and that you are awesome. You taught me this stuff something like 10 years ago and because you taught me HOW assays work I can still intuit my way through it today making reasonable guesses on how things work. Thanks for investing in me.

Systems Engineer
Former colleague

Contact

Let’s talk about your laboratory.

Whether you’re building a new lab from the ground up, navigating a complex regulatory submission, seeking CAP or NYSDOH inspection support, or looking for expert PGx interpretation — Phoenix Laboratory Consulting can help.

Request a Quote for the NYSDOH Compliance System
Emailbronwynr@phoenixlabconsulting.com
Websitephoenixlabconsulting.com
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