Provides an extensive set of assessments for impurity qualification, covering genotoxicity and systemic toxicology studies. Additionally, offers in-silico screenings based on QSAR for ANDA and other submissions.
Analytical Testing
Essential components of regulatory filings alongside the development of methods, characterization, and analysis of dosage formulations for test materials.
Incorporate both in vitro and in vivo investigations to identify potential carcinogenic or mutagenic agents capable of inducing genetic changes in somatic or germ cells. Additionally, assess the potential for DNA damage that could impact chromosomal structure or disrupt the mitotic apparatus, leading to variations in chromosome number.