Your Partner in Quality, Compliance and Profitability.
Real laboratory experts with direct laboratory experience.
Who We Are
Our Work
Our Services
Our Work
Laboratory Pros provides clinical laboratories with the tools and skills they need to thrive while successfully navigating complex and evolving regulatory requirements.
Fully compliant laboratories that are functional, profitable, growing and competitive are the hallmarks of our work.
Our Team
Our Services
Our Work
Our small team of industry experts has over 30 years of combined experience in biomedical and research laboratories, and process management and strategic planning. Through a truly collaborative peer-to-peer approach, we provide focused guidance and customized services to solve a laboratory’s specific needs and achieve its goals quickly and comprehensively.
Our Services
Our Services
Our Services
- LDT/IVD transition and FDA compliance
- QMS design and optimization
- 3rd party audits, inspection preparation and support
- Vendor qualification
- Study Design
- Clinical Trial Protocol Development
- More ...
Full List of Services
- LDT/IVD transition (complying with increased FDA oversight of LDTs)
- Establishing, enhancing, and optimizing Quality Management Systems for laboratory businesses
- Conducting 3rd-party audits and mock inspections of laboratory operations
- Inspection preparation and support
- Vendor qualification
- Study design
- Clinical trial protocol development
- Clinical affairs and clinical operations leadership: site/team preparation and study start up through closeout to launch
- Recruiting, building and training clinical teams
- Partnering with pharma companies to provide CRO services and the laboratory portion of clinical trials
- Providing gap assessments against regulatory obligations
- Guiding process improvement initiatives
- Clinical laboratory risk management
- Achieving accreditation through the CAP, The Joint Commission, COLA, and/or ACHC.
- Building and maintaining a culture of compliance
- Laboratory lifecycle management
- Establishing a new laboratory, laboratory expansion, relocating an existing laboratory, merging two or more existing laboratories, suspending services and/or closing a laboratory
- Test method validation and verification
- Workflow optimization
- Identifying and resolving nonconforming events and performance issues
- Configuring and streamlining change management and design control programs
- Navigating leadership transitions
- Computer system validation
- Regulatory experience includes, but is not limited to the following:
- CLIA (42 CFR Part 493)
- ISO 15189 and 13485
- Quality System Regulation for devices intended for human use (21 CFR Part 820)
- FDA Regulations Relating to Good Clinical Practice and Clinical Trials
- Electronic Records, Electronic Signatures (21 CFR Part 11)
- Regulatory Hearing Before the Food and Drug Administration (21 CFR Part 16)
- Protection of Human Subjects (Informed Consent) (21 CFR Part 50)
- Financial Disclosure by Clinical Investigators (21 CFR Part 54)
- Institutional Review Boards (21 CFR Part 56)
- Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR Part 58)
- Investigational Device Exemptions (21 CFR Part 812)
- Premarket Approval of Medical Devices (21 CFR Part 814)
- New York State Clinical Laboratory Standards
- California Codes Rules and Regulations and the California Business and Professions Code as they relate to the conduct of clinical laboratories.
- Companion Diagnostics (CDx)
- Financial analysis and planning advice
- Business analysis (internal, external, competitive factors and operational frameworks)
- M&A integration
- Media training for executives and crisis communications support
Contact Us
If you have any questions or would like to learn more about our laboratory services, please don't hesitate to contact us at (619) 800-6699 or through the form below. Our consultations are free and we are always happy to hear from our fellow industry associates.