Company Overview
The World’s Leading Nicotine Product Testing Laboratory
As part of Certified Group, Labstat is committed to delivering high-quality technical solutions our customers can feel confident in – on time, every time – so the world can trust in what it consumes. As one of the world’s largest independent testing laboratories, Labstat specializes in analytical chemistry, in vitro toxicology, microbiology, method development, and customized technical services for global clients in the tobacco, nicotine, cannabis, hemp, and natural health product categories.
We Are Focused On What Is Important to Our Clients:
Scientific leadership
A collaborative approach to provide meaningful technical solutions
Breadth of testing capabilities
Producing reliable and defensible results
Fast reporting times
Scientific Leadership, Experience and Solutions to Support Our Clients Diverse Needs
We have been testing nicotine containing products since 1976. During this period, our scientific personnel have acquired the most extensive technical experience in the industry. This experience spans the entire product life-cycle:
Research and product development
New market launches
Stewardship
Regulatory reporting
Scientific Leadership in Cannabis Testing
Our scientific and technical leadership is not limited to nicotine containing products. Our cannabis testing experience in both chemistry and in-vitro toxicology dates back to 2003. We are the only laboratory in the world that can offer the scope of testing services for cannabis vapor and smoke.
Breadth of Testing Capabilities
Nicotine Containing Products
Labstat has the most comprehensive testing and product stability services in the industry testing the broadest list of product categories:
Cannabis
Like our nicotine containing product testing capabilities we also have the most extensive list of cannabis testing and product stability services in the industry testing the broadest list of product categories:
Regulatory Testing Capabilities
Our chemistry, in-vitro toxicology and microbiology testing capabilities support regulatory testing requirements around the world including:
Food and Drug Administration (FDA)
- FDA Premarket Tobacco Product Applications (PMTA ENDS and all other tobacco and FDA CTP deemed products)
- FDA Harmful and Potentially Harmful Constituents (HPHCs: TPSAC HPHC list)
- FDA Modified Risk Tobacco Product Applications (MRTP: ENDS and all other tobacco and FDA CTP deemed products)
- FDA Substantial Equivalence
Other Global Regulatory Testing Requirements
- Canada: Health Canada
- Brazil: Anvisa
- EU TPD
- Countries in the Middle East, Africa and South America that require testing data to support tobacco and nicotine containing product regulations.
Quality Management: Data You Can Trust
In highly regulated and rapidly changing markets, our clients count on us to provide them with reliable and defensible data. We embrace this responsibility by implementing and adhering to a rigorous set of quality standards.
Our Quality Management System is the backbone of the standards we hold ourselves accountable to. Our quality system focuses on 3 foundational elements:
Testing Capacity
The Fastest Turnaround Times in the Industry
Labstat operates the world’s largest nicotine containing product chemistry, in-vitro toxicology and microbiology testing laboratory providing our clients with the quickest turnaround times in the industry.
Regulatory Consulting
Labstat offers its clients a comprehensive list of regulatory consulting services. Our consultants have extensive experience managing everything for a PMTA ENDS application to GMP auditing.
Our services include:
- Implementation and filing complete FDA ENDS PMTA applications
- GMP quality systems implementation and GMP compliance auditing for both nicotine containing products and cannabis products.
- Tobacco registration, label and market reviews and 483 Warning Letter Remediation