LAUNCH
Colaborate is a full-service laboratory consulting company located in Tampa, Florida. We have proudly served clients across the country for over 20 years. Specializing in new laboratory builds, our team is made up of business, medical, technical, and advisory experts.
Whether you are building a brand-new startup laboratory or are looking to expand testing and add new technologies, our team will help guide you through every step of the process. With so many details to oversee and decisions to be made, it is crucial to partner with laboratory startup consultants that are knowledgeable and trusted in the industry. From applications and planning to compliance and inspections, we offer a wide range of services to help meet the goals and needs of our clients.
Colaborate is proud to have served over 500 companies across the US. From toxicology labs to mobile laboratories, we work to fast track your startup laboratory project. We also specialize in mergers and acquisitions, health system and laboratory integration services and more.
Looking for Project Consultancy for Your Laboratory?
Whether you need assistance with one or two components of your lab or are looking for a full project build, Colaborate offers a team of consultants to help you reach your goals. Our lab project consultants are knowledgeable and experienced in areas ranging from overall strategy to IT optimizations, compliance and regulations, inspections, and more. We specialize in serving health systems, academic centers, clinical laboratories, and other organizations..
With more than 20 years in business, Colaborate has partnered with more than 500 organizations, helping setup new laboratories as well as offering lab project management consultancy. We understand no two labs are the same, yet all are challenged to sustain growth, compete, and remain compliant in a highly complex environment. Contact us today to learn more about our laboratory management consultants.
Starting a Clinical Laboratory
How much does it cost to start a clinical laboratory?
Startup costs depend on your test offerings, volume, and complexity level. Here’s what we see across the 2,500+ labs we’ve worked with:
| Lab Type | Starting Investment | Timeline |
|---|---|---|
| Waved | Starting at $10K | 4 – 6 weeks |
| Moderate Complexity | Starting at $50K | 6 – 18 weeks |
| High Complexity | Starting at $200K | 8 weeks – 1 year |
These figures cover equipment, supplies, your LIS (laboratory information system), facility buildout, personnel, and consulting support. Timelines may vary depending on state regulatory requirements for laboratory licensure and operation. A feasibility assessment early on helps you budget accurately and avoid surprises.
What are the steps to start a clinical laboratory?
We’ve helped launch thousands of labs. Here are the six phases every successful build follows:
1. Business Planning – Market analysis, financial projections, test menu strategy
2. Facility & Design – Site selection, lab layout, equipment planning
3. Licensing – CLIA registration, state licensure (if required)
4. Personnel – Laboratory director, technical staff, training
5. Quality Systems – SOPs, QC/QA programs, proficiency testing
6. Validation & Go-Live – Method validation, LIS testing, inspection
A smooth launch comes down to building quality systems early, submitting complete applications the first time, and planning realistic timelines from day one. Our Lab Startup Checklist walks through each phase in detail.
Which states require a laboratory license beyond CLIA?
Fifteen states have additional licensing requirements beyond federal CLIA. If you’re accepting specimens from patients in these states, plan ahead for additional paperwork and processing time:
| State | Requirement |
|---|---|
| Arizona | State registration for certain facilities |
| California | CDPH license + licensed personnel (CLS, MLT) |
| Connecticut | State license required |
| Florida | State personnel licensure required |
| Georgia | State license for certain lab types |
| Hawaii | State license for clinical labs |
| Maine | State license required |
| Maryland | State permit required |
| Massachusetts | State laboratory license required |
| Nevada | State license required |
| New Jersey | Bioanalytical director license |
| New York | CLEP permit (CLIA-exempt state) |
| Pennsylvania | State permit (tied to director) |
| Rhode Island | State license required |
| Washington | Medical Test Site license |
California and New York are the most involved; plan for several extra months if you need licensure in either state.