01
Quality & Compliance
FDA 21 CFR Part 1271 readiness, donor eligibility, SOPs, CAPA, audits, licensing, training and ongoing quality oversight.
Discuss this practiceU.S. donor program consultancy
Build it right.
Run it better.
One specialist team to build, protect and grow reproductive tissue banks, donor programs and laboratories.
01 Science at the center
Biology, systems and strategy—
aligned around one purpose.
aligned around one purpose.
25+Years in reproductive health
25+FDA tissue inspections guided
2,000+Children through hands-on embryology
Founder-led expertise.
Specialist-powered execution.
What we solve
Expertise that moves
with your program.
From an empty floor plan to a high-performing donor operation, we connect strategy to implementation.
02
Laboratory Build-Out
From feasibility and workflow design through equipment planning, validation, staffing, commissioning and inspection readiness.
Discuss this practice03
Egg Donor Programs
Program design, donor recruitment, screening workflows, cycle coordination, vitrification strategy and clinic integration.
Discuss this practice04
Operations & Management
Workflow, staffing, inventory, distribution, vendor management, metrics and fractional leadership that keep programs moving.
Discuss this practice05
Sales Representation
Clinic targeting, commercial readiness, account development, contracting support and U.S. representation for qualified programs.
Discuss this practice06
Marketing & Growth
Precise positioning, donor recruitment strategy, clinic education and campaigns built for reproductive healthcare.
Discuss this practiceLaboratory build-out
From floor plan
to first collection.
A reproductive laboratory is more than equipment in a room. We align the facility, workflow, quality system, people and regulatory pathway so your operation is ready for the work it was designed to perform.
Plan your laboratory
Plan
Feasibility, scope, regulatory pathway, capacity and financial assumptions.
Design
Workflow, equipment, vendors, storage, utilities and contamination controls.
Validate
SOPs, quality systems, qualification, training and operational simulations.
Launch
Licensing, inspection readiness, commissioning and post-launch optimization.
We coordinate with qualified architects, engineers, contractors, laboratory vendors and counsel as the project requires.
Operational precision
Quality you can
see—and trace.
Strong donor programs make control visible from eligibility determination through storage, distribution and follow-up.
01Controlled workflows
02Documented decisions
03Accountable ownership
Who we serve
Built for the people
building families.
Focused exclusively on the organizations responsible for donor care, tissue quality and reproductive outcomes.
Fertility clinics
Launch, standardize or strengthen internal donor services and laboratory operations.
Sperm banks
Improve quality systems, operations, clinic sales and sustainable market reach.
Egg banks & agencies
Build compliant programs from donor recruitment through vitrification and distribution.
Fertility platforms
Evaluate acquisitions, integrate programs and establish consistent systems across locations.
How we work
Advice is only useful
when it becomes action.
Every engagement is structured around decisions, ownership and measurable implementation—not a report left on a shelf.
- 01DiagnoseFind the risks and opportunities that matter.
- 02DesignBuild the practical plan, system and measures.
- 03ImplementWork beside your team through execution.
- 04StrengthenMonitor, train and improve performance.
Founder expertise
“The best donor programs make quality visible in every decision.”
Corey Burke Founder & CEO
Experience built
inside the work.
Corey Burke brings more than 25 years across andrology, embryology, reproductive tissue banking and donor-program leadership.
His experience includes hands-on embryology, directing tissue banks, establishing sperm and egg bank operations in the United States and abroad, developing donor programs, and guiding organizations through more than 25 FDA tissue inspections. ReproDonor Solutions turns that operating experience into practical support for the next generation of U.S. donor programs.
1998Andrology and embryology
2005Tissue bank leadership
TodayReproDonor Solutions
Start here
What does your
program need next?
Begin with a focused conversation about the challenge, the opportunity and what success should look like.
Talk with Corey