The world of drug discovery is a constant pursuit of innovation, aiming to create life-saving medications and treatments. However, ensuring the safety of these potential therapies is an important part of the process. This is where toxicology comes in—a scientific discipline dedicated to evaluating the adverse effects of chemicals, drugs, and environmental contaminants on living organisms.

At Envol Biomedical, we offer comprehensive toxicology services designed to meet the rigorous demands of preclinical drug development. Our team of highly qualified toxicologists leverages cutting-edge methodologies and the largest non-human primate (NHP) population in the continental US to provide unparalleled accuracy and efficiency in your safety assessments.

Comprehensive Toxicology Assessments

Understanding a substance's potential for harm is crucial for responsible development. Our toxicology assessments encompass a wide range of studies, meticulously designed to unveil a comprehensive safety profile:

● Acute Toxicity: Evaluating the immediate and severe effects of a single high dose.
● Repeat-Dose Toxicity: Assessing the adverse effects of repeated administration over a specific period.
● Genotoxicity: Determining the potential for a substance to damage genetic material.
● Carcinogenicity: Evaluating the potential for a substance to cause cancer.
● Reproductive and Developmental Toxicity: Assessing the effects on fertility, pregnancy, and offspring development.
● Safety Pharmacology: Evaluating a substance's potential to impact vital physiological functions like heart rate, respiration, and blood pressure.

We employ a variety of sophisticated techniques to gather robust data, including:

● Clinical observations: Monitoring animals for behavioral changes, physical signs of distress, and mortality rates.
● Clinical pathology: Analyzing blood and other bodily fluids to assess organ function and identify potential damage.
● Histopathology: Microscopic examination of tissues to detect abnormalities at the cellular level.
● Immunotoxicity: Evaluating a substance's impact on the immune system.

By integrating these methods, we provide a holistic picture of a substance's potential toxicity, empowering you to make informed decisions during drug development.

Unmatched Expertise in Non-Human Primate Studies

Non-human primates (NHPs) share a close physiological and genetic similarity with humans, making them the gold standard for preclinical toxicology studies. At Envol Biomedical, we boast unparalleled expertise in NHP research, offering several distinct advantages:

  • Largest NHP Population in the US: Gain immediate access to a vast pool of healthy NHPs, including cynomolgus macaques, marmosets, squirrel monkeys, and African greens.
  • Experienced Primate Handlers: Our dedicated team ensures the ethical treatment and well-being of all primates throughout the study.
  • Diverse Disease Models: Leverage our expertise in creating disease models that mimic human conditions, allowing for targeted safety assessments.
  • Specialized Dosing Techniques: We offer a comprehensive range of dosing routes, including oral gavage, inhalation, intravenous injection, and topical application, replicating real-world administration methods.

Our in-depth understanding of NHP biology, coupled with our state-of-the-art facilities, allows us to conduct highly controlled and reliable studies. This translates to robust safety data that confidently predicts a substance's potential effects in humans.

Flexible Toxicology Study Design and Execution

We understand that every drug development program has unique needs. Our team of toxicologists works closely with you to design a customized study plan that aligns with your specific requirements, regulatory considerations, and timelines. We offer the following flexibilities to ensure a seamless and efficient toxicology program:

  • Study Design Customization: Choose from a comprehensive menu of toxicology studies, or collaborate with us to create a bespoke program tailored to your specific molecule.
  • Dose Selection: We assist in determining the appropriate dose range for your study, considering factors like potency, therapeutic window, and anticipated safety profile.
  • Study Duration: Whether you require an acute toxicity study or a comprehensive repeat-dose program, we can accommodate your research timeline.
  • Sample Analysis: We offer a wide range of analytical services to support your toxicology studies, including bioanalysis, toxicokinetics, and biomarker identification.

Our commitment to flexibility extends beyond the initial study design. We understand that the course of drug development can be dynamic, and we are responsive to any modifications or adjustments necessary throughout the testing process.

Navigating the complexities of drug development requires a trusted partner with the expertise and resources to ensure the safety of your potential therapies. At Envol Biomedical, we offer a comprehensive suite of toxicology services designed to meet your specific needs. Our team of highly qualified toxicologists, unparalleled expertise in NHP studies, flexible study design capabilities, and commitment to high-quality data delivery position us as your ideal partner for success. Contact us today to discuss your toxicology testing requirements and let us help you bring your life-saving treatments to the world with confidence.

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