Over our more than two decades’ experience with drug chemistries, EAG has worked with virtually every type of veterinary medicine and feed additive for livestock and companion animals. We provide NADA-and INAD-enabling, registration, and post-commercialization support and lifecycle management of veterinary medicines, pesticides, parasiticides, and other therapies, including biologics. EAG scientists have helped many companies like yours answer challenging development questions, respond to regulators and uncover sources of problematic manufacturing issues regarding veterinary drugs.
How do you adhere meet the myriad of regulations required for veterinary drugs? Turn to EAG. WE KNOW HOW.
HOW WE CAN HELP
- 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
- Animal metabolism: GLP-compliant plant and animal metabolism services required to demonstrate safety, distribution and metabolism of chemical substances, including bioaccumulation and the radiochromatographic profiling, isolation and identification of metabolites
- Radiolabeling & custom synthesis: Stable-label, radiolabel, and custom synthesis; cGMP/GLP radiolabeling in support of DMPK, ADME and mass balance studies; reference standard synthesis; with dedicated analytical support for generation of certificates of analysis
- Environmental assessments: The full package of required product chemistry, ecotoxicology and environmental fate testing, including synthesis of 3H or 14C-labeled materials for metabolism studies required to understand the environmental impacts of livestock medicines and certain other animal health products
- Litigation support: Supporting manufacturers of veterinary drugs when issues of patent litigation, product liability or insurance defense arise.