Laboratory compliance & development
Phoenix Laboratory Consulting provides expert guidance in laboratory development, regulatory compliance, NYSDOH licensure, and CAP accreditation — from concept through launch.
Two decades building, directing, and transforming clinical molecular diagnostic laboratories.
Founder & principal consultant
Bronwyn Ramey is a pharmacogenomics leader with over two decades of experience building, directing, and transforming clinical molecular diagnostic laboratories. 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.
She serves as a contract laboratory director, sits on standards and expert committees in pharmacogenomics, and inspects and assesses laboratories for CAP and EMQN — which means she prepares laboratories for inspections she also knows from the other side of the table.
| Credential | Issuing body |
|---|---|
| PhD, Microbiology & Biochemistry | Indiana University |
| Postdoctoral fellowships — microbial pathogenesis; pharmacogenetics | Univ. of Iowa · PGXL Labs |
| HCLD — High-complexity clinical laboratory director | American Board of Bioanalysis |
| MB(ASCP) — Technologist in Molecular Biology | ASCP |
| CGMBS — Clinical Genetic Molecular Biologist Scientist | California Dept. of Public Health |
| Certified pharmacogenomics laboratory director | New York State |
| Role | Organization |
|---|---|
| Chair, Evidentiary Standards Committee | STRIPE Collaborative Community |
| Member, CYP2D6 & CYP3A Expert Committees | PharmVar |
| Assessor, Pharmacogenomics and DPYD/UGT1A1 schemes | EMQN |
| Inspector | College of American Pathologists |
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.
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.
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.
Expert guidance through New York State licensure, permit applications, and CLEP requirements — structured to minimize deficiencies and accelerate approval timelines.
Preparation and submission of LDT approvals and test modification packets. Scientific and regulatory documentation that gets your technology investment into productive clinical use.
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.
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.
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.
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.
A documented implementation system for New York State licensure — available on its own, or with hands-on support. Three ways to license it.
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.
How to get it Tell us which option fits and we will send scope, terms, and pricing — usually within two business days. Purchase orders and invoicing are supported for laboratories that cannot buy by card.
Full system access for one laboratory — for labs managing their own NYSDOH compliance process.
Direct purchase opening soon at phoenixcomplianceshop.com Buy directly at phoenixcomplianceshop.comSystem access plus consulting support for guided, hands-on implementation.
Quoted per laboratoryFor independent laboratory consultants deploying the system across client engagements.
Quoted per consultancyFree warfarin preview (CYP2C9, VKORC1) — no sign-up.
Choosing Coriell reference controls for a pharmacogenetic validation usually means cross-referencing panel content, GeT-RM diplotypes, and 1000 Genomes carriers by hand. This tool does it in minutes: map your platform's targets to the reference samples that carry them — including CYP2D6 copy-number and hybrid controls — and export an audit-ready control set.
What is inside
Phoenix Compliance Shop The Control Finder and the NYSDOH Single-Laboratory License are moving to a dedicated storefront, phoenixcomplianceshop.com — buy and download, no call required. Opening soon. Buy the Control Finder and the NYSDOH Single-Laboratory License directly at phoenixcomplianceshop.com — download immediately, no call required.
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.
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 Consulting 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.
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.
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.
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.