FDA Pre-Clinical Toxicology

GLP testing for the Food and Drug Administration

Pre-Clinical Safety

  • MB Research provides industry-leading general toxicology services for the pharmaceutical, biotechnology, and medical device industries and government agencies.
  • Routine and non-traditional toxicology studies are performed, custom testing services to meet specific testing needs is available.
  • In Vitro and In Vivo Toxicology Tests
  • Study Directors and technicians strive to consistently deliver exemplary results to support both Good Laboratory Practices(GLP) and non-GLP studies. What's GLP?

Biocompatibility Testing

Medical Device Testing

In vitro & in vivo biological compatibility/safety evaluations are conducted on biomaterials, medical devices, and related products to identify potential risks for the use of a device in humans. Biocompatibility testing ranges from the screening of new materials to product release testing, audit testing, and pre-market safety evaluations to meet current FDA guidance and ISO 10993 standards.

Testing Parameters include exposure durations options, such as, Limited, Prolonged and Permanent. Many contact options are also available: Skin, Mucous Membrane, Breached or Compromised Surfaces, Blood Path (Indirect), Tissue, Bone, Dentin, and Circulating Blood. Extraction options are configurable to meet your specific ISO requirements.

Drug Discovery Services

Biocompatibility Testing

In vitro & in vivo biological compatibility/safety evaluations are conducted on biomaterials, medical devices, and related products.

OECD Guidelines for the Testing of Chemicals

OECD Test Guideline Protocols Commonly Performed at MB Research Labs

Specialty Exposure Testing

Regulatory compliant testing with customized study design available.

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.