Noble Life Sciences is a leading contract research organization (CRO) specializing in toxicology studies for the biotech, pharmaceutical, and biopharmaceutical industries. With our state-of-the-art facilities and highly skilled team of scientists, we provide comprehensive non-GLP toxicology services tailored to meet our clients’ specific needs.
Value of Non-GLP Studies
Non-GLP (Good Laboratory Practice) studies offer valuable insights and benefits in the early stages of drug development. While GLP studies are required for regulatory submissions, non-GLP studies serve as a cost-effective and flexible approach for initial evaluations, allowing for quicker decision-making and optimization of resources. The key value of non-GLP studies includes:
- Exploratory Research: Non-GLP studies provide a platform to explore a wide range of doses, formulations, and exposure durations, enabling researchers to gather preliminary data and make informed decisions about further development.
- Rapid Screening: Non-GLP studies offer the advantage of faster turnaround times, making them suitable for screening multiple compounds or evaluating early-stage candidates.
- Customization and Flexibility: Non-GLP studies allow for customized study designs, including specialized assessments and modifications, based on the unique requirements of the compound being tested.
- Cost-Effectiveness: Non-GLP studies are typically more cost-effective than GLP studies, making them an attractive option for companies operating within budget constraints during the early stages of drug development.
- Decision-Making: Non-GLP studies provide critical data and insights that contribute to informed decision-making regarding the further progression of compounds in the development pipeline.
- Dose Ranging Studies: Our experienced team designs and executes dose ranging studies to determine the appropriate dosage levels for subsequent toxicity evaluations.
- Acute Toxicity Studies: We conduct acute toxicity studies to assess the adverse effects of single or short-term exposure to test compounds.
- Repeated Dose Studies: Our facility is equipped to perform repeated dose studies, evaluating the effects of prolonged exposure to test substances over various timeframes.
- Subchronic and Chronic Studies: We offer subchronic and chronic toxicity studies to assess the long-term effects of repeated exposure, helping our clients evaluate the safety profile of their compounds.
- Genotoxicity Studies: Our experts conduct genotoxicity assessments to evaluate the potential of test compounds to cause genetic damage or mutations.
- Carcinogenicity Studies: We perform carcinogenicity studies to determine the potential of test substances to induce the development of cancerous tumors.
Founded by accomplished industry scientists
Noble offers everything needed to run a successful preclinical study:
24,000 square feet fully-equipped facility
AAALAC accredited small and large animal facility
Full continuum of GLP and non-GLP services
Spectrum of in vitro and in vivo services
Frequently Asked Questions (FAQs) About Non-GLP Toxicology Studies
What is the difference between GLP and non-GLP studies?
GLP (Good Laboratory Practice) studies are conducted according to a set of regulatory guidelines and are required for data submission to regulatory authorities. They involve strict quality control measures and detailed documentation. Non-GLP studies, on the other hand, are exploratory in nature and serve as an early evaluation tool. They are more flexible, cost-effective, and offer faster results but do not adhere to the rigorous regulatory standards of GLP studies.
What is a non-GLP study?
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Discover the power of tailored dPCR services by reaching out to us today, and let us customize our offerings to meet your specific research needs.