Team Elexes 
Compliance Assurance
Stay compliant with industry regulations and standards.
Cost-effective
Achieve regulatory success with Elexes, all within your budget.
Laboratory Consulting Services for Clinical, Biotech & Testing Labs
Whether you're establishing a new lab or optimizing an existing one, Elexes offers end-to-end laboratory consulting services to meet your technical, operational, and regulatory needs. From lab design to accreditation and SOP development, we empower laboratories across clinical, biotech, and diagnostic sectors to achieve excellence.
Why You Need Laboratory Consulting Services?
In a competitive and highly regulated landscape, laboratories must do more than just test samples, they must operate with precision, safety, and compliance. That’s where expert laboratory consulting services come in. Elexes enables labs to thrive by bringing strategic insight, regulatory expertise, and operational finesse to every project.
Lab Setup & Design
Starting a lab from scratch is an intricate process. From biosafety to HVAC zoning and clean room classifications, our consultants guide you through every step of facility layout, lab zoning, and equipment procurement. We focus on maximizing lab functionality while meeting standards such as OSHA, CDC guidelines, and ISO 15189.
Compliance & Accreditation
Regulatory compliance is not optional, it’s the cornerstone of credible laboratory operations. We assist with CLIA registration, CAP inspections, ISO 17025 and ISO 15189 accreditation, and other national and global standards. From documentation to audits and proficiency testing readiness, we keep your lab inspection ready year round.
Process Optimization
An optimized lab reduces errors, improves turnaround time, and increases profit margins. We evaluate your current workflows, quality control checkpoints, and staffing efficiency to propose leaner processes, automation opportunities, and better data integrity practices. We make sure your lab runs smarter, not harder.
Expert CLIA Laboratory Setup and Accreditation Support
Whether you're building a clinical diagnostics lab, analytical testing facility, or a food and pharma lab, Elexes provides the technical backbone you need. We help you design compliant, scalable, and future-ready laboratory environments, ensuring everything from bench layout and clean zones to utility connections and waste management aligns with local and international codes.
Our services include vendor and equipment evaluation, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). We also draft customized SOPs that support good laboratory practices (GLP), data traceability, chain-of-custody processes, and effective cross-functional team collaboration.
If you're expanding, relocating, or renovating, we also support gap assessments, risk evaluations, and change control to ensure continuity and compliance.
Service Offerings
Comprehensive Lab Setup & Expansion
⦿ Lab design and equipment planning
⦿ Utility and biosafety development
⦿ Space planning for clinical, analytical, or research workflows
Regulatory Compliance & Accreditation
⦿ Assistance with CLIA, CAP, ISO 15189, and GLP certification
⦿ SOP development and document control systems
⦿ Training for compliance, QA, and lab personnel
Operational Excellence & Quality Systems
⦿ Workflow optimization for turnaround time
⦿ Quality control and performance evaluations
⦿ Internal audits and continuous improvement plans
Digital Transformation, LIMS Integration & Data Integrity
Laboratories today deal with complex datasets, instrument-generated outputs, and regulatory audits that demand secure and auditable systems. Elexes helps your lab embrace digital transformation by selecting and validating fit-for-purpose Laboratory Information Management Systems (LIMS), Electronic Lab Notebooks (ELN), and lab automation tools.
Our consultants ensure that your lab systems are compliant with FDA 21 CFR Part 11, ALCOA+, and HIPAA standards, where applicable. We support you from system requirements drafting to vendor negotiation, data migration, software IQ/OQ/PQ, and staff training.
We provide regulatory-informed digitalization strategies that enhance lab accuracy, data reliability, and audit preparedness. If your lab is still paper-heavy, we help you transition to hybrid or paperless operations without losing compliance fidelity.
Navigating Your Lab's Compliance and Operational Roadmap
Choosing the right certifications and knowing where your lab stands, whether you're starting up or scaling, is crucial. These infographics offer a simplified view of key accreditation pathways and service needs based on your lab’s stage and type.
FAQs
Frequently Asked Questions!
Elexes supports clinical, analytical, biotech, diagnostic, and pharmaceutical testing laboratories.
Yes, we provide full support for CLIA, ISO 15189, CAP, and other accreditation requirements.
Yes, our consultants help with LIMS selection, integration, validation, and compliance with 21 CFR Part 11.
Quick Turn around
Experience timely results with our efficient services.
Confidentiality guaranteed
We offer 100% confidentiality understanding how critical the data is for you.
Elexes offer complete range of regulatory and compliance expertise, ensuring full-support in product development and post-market compliance. Get everything under one roof for your medical device!
Associated Regulatory Authorities.
We’ve More
Than 256+ Global
Clients
The Best RA & QA Consultants
Clients Testimonials
Amazing Feedback About Our Services
Tom Birney
CEO Masterlink, Arizona
“
Elexes gave us immense support. Their Knowledge and thoroughness were excellent. I look for all of these qualities in consulting firms
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Diane Bryant
CEO Novasignal, Los Angeles
“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.
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Daniel Kinsey
President ViDava, Florida
“Professional and easy to work with! They expedited CE Marking for our products and also created clinical evaluations, risk assessments, and provided testing/manufacturing advice.
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Linda Pan
Sr. Exe Treedental, Hong Kong
“Having Elexes as our import-export expert was a great choice. Elexes' team answered all our questions and guided us through every step.
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Joshua Mink
Manager Outset Medical, California
“Highly recommend Elexes! They always meet commitments and follow through on action items.
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Michal Depa
CTO Jana Care, Massachusetts
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product's nuances quickly.
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Philip McFerran
MD Blackrock Pharma, England
“Kudos to the Elexes team! They're always proactive and have provided invaluable support to us with import, labels, and registrations.
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Samip Shah
VP Regulatory AliveCor, California
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.
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Elizabeth W
Owner Liz Inc., Arizona
“Accurate and amazing! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time.
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Kurt Sysock
CEO Radformation, New York
“Elexes is a go-to for all FDA regulatory and quality systems work. They outperformed every expectation!
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