Veterinary Drug Testing
Over our more than two decades’ experience with drug chemistries, Eurofins Regulatory Science Services has worked with virtually every type of veterinary medicine and feed additive for livestock and companion animals.
We provide VICH, NADA and INAD-compliant testing, registration, and post-commercialization support and lifecycle management of veterinary medicines, pesticides, parasiticides, and other therapies, including biologics. Our scientists have helped many companies answer challenging development questions, respond to regulators, and uncover sources of problematic manufacturing issues regarding veterinary drugs.
Our veterinary drug testing capabilities include:
- Metabolism: We offer all of the GLP-compliant metabolism services needed to demonstrate safety, distribution, and metabolism of chemical substances, including bioaccumulation studies and the radio-chromatographic profiling, isolation, and identification of metabolites.
- Environmental assessments: We offer a comprehensive package of product chemistry, ecotoxicology, and environmental fate testing, including synthesis of 3H or 14C-labeled materials for metabolism studies required to determine the environmental impacts of livestock medicines and certain other animal health products.
- Animal health services: We specialize in the design, management and execution of pre-clinical and clinical studies in companion and production animals. Our studies can be conducted to Good Clinical Practice (GCP) or Good Laboratory Practice (GLP) standards as needed by our clients.
- Radiolabeling & custom synthesis: Stable-label, radiolabel, and custom synthesis; cGMP/GLP radiolabeling in support of DMPK, ADME, and mass balance studies; reference standard synthesis; dedicated analytical support for generation of certificates of analysis
Additional services offered through the Eurofins Scientific Network:
- Chemistry, manufacturing & controls (cGMP): Comprehensive analytical support and quality control for API and drug product under cGMP, including analytical method development and validation, raw material and component testing, registration stability and post-marketing programs, reference standard management, QC release testing, and full extractables and leachables programs.
- Trace analysis & structural chemistry: In-house expertise in the isolation, identification, and characterization of trace impurities to support stability programs, degradation pathway studies, compliant sample testing, and product and process investigations.
- Research, safety, residues and efficacy studies: Bioanalytical method development and validation in tissues; ADME/ Mass Balance studies; metabolite identification and dose formulation.
Contact erssinfo@eurofins.com for more information!
