Drugs and Bioscience
Life Science Regulatory Services
Pharmaceutical, and Biotechnology Toxicology Study
Toxicology Consulting Services for Life Science Industry
During the preclinical phase of a drug or life sciences product, you are required to conduct a toxicology study to assess potential health risk associated with a new product. But how can you know which type of preclinical toxicology report is best to perform your product? And how can you be sure that you are meeting each guideline as set forth by the Federal Food and Drug Administration (FDA)? This is where JJCC Group can help you.
Obtain regulatory approval for your product in Life Science with the help of JJCC Group consultants. Our board-certified toxicologists, scientists, researchers, statisticians, and expert regulatory compliance consultants boast years of experience in the process development of life science products and protecting human health through regulatory compliance oversight.
Our toxicology consulting services include (but are not limited to):
- Toxicology study design
- Health Risk Assessment of drug and other life science products.
- Full toxicology reports
- Safety Data Sheet.
What is a Toxicology study?
A toxicology study (in-vitro vs. in-vivo) is conducted on a drug, or a life science product to assess the potential risk of such a drug, medical devices, or other life science product on living subjects, from rodents to humans. Toxicity testing can be very specific for a particular effect, such as dermal irritation, or it may be general, such as testing for unknown chronic effects. standardized tests have been developed for the following effects:
- Acute Toxicity
- Sub-chronic Toxicity
- Chronic Toxicity
- Reproductive Toxicity
- Developmental Toxicity
- Dermal Toxicity
- Ocular Toxicity
- Genetic Toxicity
Why do I Need a Toxicology Study?
The entire purpose of a toxicology study is to determine whether or not your drug could be harmful to future consumers. Before an organization can enter the clinical trial phase for their pharmaceutical product or other life science product, they must first run studies and determine whether or not this drug could be potentially harmful to people, the environment, or animals.
However, abiding by good laboratory practice (GLP) guidelines set forth by the Food and Drug Administration can be taxing, time-consuming, and costly. These guidelines set high standards for equipment, processes, testing procedures, and more. Hiring regulatory compliance consultants to ensure you are able to run a thorough toxicology report that satisfies each requirement by the FDA and other regulatory bodies (including the EPA or OECD) may pay you in dividends.
Receive regulatory compliance assistance in toxicology reporting and gain full approval of food products, pharmaceutical industry products, and other life science products with JJCC Group’s expert regulatory compliance consultants. We’ll help you bring your product to (daily) life.