GHS Report

Safety studies (General and Genetic Toxicology)

We offer a variety of services within both GLP and Non-GLP settings encompassing fields such as analytical chemistry, general toxicity studies, genetic toxicity assessments, toxicokinetics/pharmacokinetics analyses, developmental and reproductive toxicology (DART) investigations, and bioanalysis. These services support the development of pharmaceuticals, biosimilars, vaccines, nutraceuticals, herbal remedies, and the safety evaluation of agrochemicals. All activities adhere to global regulatory standards set forth by organizations like OECD, ICH, and EMA, ensuring compliance for regulatory submissions worldwide.

Incorporate a combination of in vitro and in vivo investigations aimed at identifying potential carcinogenic or mutagenic substances capable of inducing genetic changes in somatic or germ cells. These studies also assess the potential for DNA damage, which may impact chromosomal structure or disrupt the mitotic apparatus, leading to variations in chromosome number.

Reproductive & Developmental Toxicity (DART)
Incorporate assessments of Developmental and Reproductive aspects in rodent species such as mice or rats, as well as in rabbits, to assess potential impacts on both male and female reproduction and developmental outcomes. Moreover, aside from these oral route evaluations, customized studies using alternative routes of administration such as IV, SC, IM, etc., tailored for different types of test substances (e.g., Pharmaceuticals, Agrochemicals, Biosimilars, Nutraceuticals, Herbal products, etc.), can also be conducted, following GLP or Non-GLP protocols as necessary.

Analytical Chemistry
Incorporate investigations such as physicochemical analysis, soil characterization, residue examination, environmental fate assessment, and metabolism studies, all essential components of regulatory submissions. Additionally, include activities related to method development, characterization, and dose formulation analysis for the test materials.