Regulatory Toxicology & Pre-clinical Pharmaceutical Toxicology

Your Trusted Testing Partner

QUESTION: Do Your Products Require Regulatory Safety Assessments?

We have the Experience.

MB Research Laboratories, a GLP contract research laboratory, has been conducting acute, subchronic / chronic toxicology and pharmacology studies since 1972. 

  • MB Research provides industry-leading general toxicology services for the pharmaceutical, biotechnology, medical device and agrochemical industries and government agencies.
  • Routine and non-traditional toxicology studies are performed, custom testing services to meet specific testing needs is available.
  • Study Directors and technicians strive to consistently deliver exemplary results to support both Good Laboratory Practices(GLP) and non-GLP studies. What's GLP?
With a wide range of in vivo and in vitro test protocols available, MB Research Labs offers comprehensive capabilities to to address your unique needs and goals. With expertise in many areas of in vivo and in vitro testing, research, and safety evaluations, MB Research serves the testing needs of both government and industry.

Complete support services including consultation, protocol development, quality assurance, analytical chemistry and archive facilities are integral components of studies performed at MB.  Our technical and support procedures are in full compliance with OECD, FDA, and EPA. For more information about our capabilities, please click here.

Drug Discovery Services

Regulatory Toxicity Testing

GLP safety assessment protocols that are compliant with standard regulatory requirements.

Specialty Exposure Testing

Regulatory compliant testing with customized study design available.

In Vitro Efficacy & Safety Screening

Non-GLP Efficacy and Toxicity Testing.

MB works closely with pharmaceutical companies and government agencies to help ensure the safety and efficacy of new medicines being brought to market. MB Research provides an extensive array of testing protocols that will help meet your regulatory requirements to ensure safe use of your products.

Rely on our experience in the classification of your fast moving drug candidate using both in vivo and in vitro testing models.

GLP Toxicology Assays

Good Laboratory Practice standards (GLPs) are regulations promoted in the United States by both the FDA in 21 CFR Part 58 and the EPA both for FIFRA in 40 CFR Part 160 and for TSCA in 40 CFR Part 792, as well as internationally by the OECD.

For info about GLPs: Click here.

Regulatory Testing Guidelines

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FEATURED: Cosmetic Safety Testing Roadmap to Regulatory Approval in North America, Europe and Japan

Bennett J. Varsho1, Erwin L. Roggen2, Bart De Wever3, George L. DeGeorge1

1MB Research Laboratories, Spinnerstown, PA, USA
23RsMC, Copenhagen, Denmark
3ALTEXA Development, Monte Carlo, Monaco

The cosmetics industry is a robust business, achieving greater than $250 billion in worldwide sales in 2013. Although major recognizable brands comprise the largest fraction of this total, there are thousands of small companies that operate in the same markets. While the industry association International Cooperation on Cosmetic Regulation (ICCR) seeks long-term harmonization of testing requirements, currently unaligned governmental agencies in different countries make navigation of safety requirements daunting for major manufacturers and Kafkaesque for smaller firms. While also laudable, the development, validation, approval and implementation of new non-animal safety assays often make the path to cosmetic approval seem more formidable than ever. To aid in navigation of the kaleidoscopic variables of cosmetic ingredient and final cosmetic formulation safety testing, the authors have developed a roadmap to safety assessment, focusing on requirements of the United States, the European Union, Japan and Canada.