Nonclinical Toxicology
At Vivotecnia, we conduct comprehensive carcinogenicity studies to evaluate the potential of pharmaceutical products, food additives, pesticides, and industrial chemicals to induce cancer after prolonged exposure. These studies are essential for identifying long-term risks and are a critical component of regulatory submissions to agencies such as EMA, FDA, and others.
Established — 2000
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Our carcinogenicity assessments are designed in full compliance with international regulatory guidelines, including those from ICH and OECD. This ensures that our studies meet the highest scientific standards and generate reliable data for both regulatory submissions and internal decision-making.
Both for pharmaceuticals and chemicals, carcinogenicity evaluations can be performed through 6-month short-term studies or 2-year long-term studies, depending on the regulatory requirements and the characteristics of each compound.
Carcinogenicity study designs
We offer both long-term and short term study designs to accommodate various stages of drug development and regulatory needs.
A comprehensive long-term study conducted over 24 months in rodents to assess the carcinogenic potential of a compound. This design provides detailed information on tumor development and progression and is often required for chronic exposure assessments and regulatory submissions.
A shorter-duration study designed to provide early indications of carcinogenic risk. It is particularly useful for preliminary assessments and for guiding the need for long-term studies, helping sponsors save time and optimize their development strategy.
If you are looking for a committed team,
with experience and scientific vision,
Vivotecnia is your ally in preclinical
toxicology.
