EAG scientists have worked with virtually every class and type of compound, across most indications and all common formulations of pharmaceuticals. We have contributed data to and drafted sections of IND, NDA and ANDA submissions for dozens of commercial products. And we’ve helped hundreds of companies like yours overcome R&D roadblocks, respond to regulators and uncover sources of problematic manufacturing issues.
How do you get your pharmaceutical product to market smarter, faster and with less risk?
Turn to EAG. WE KNOW HOW.
HOW WE CAN HELP
From GLP and cGMP studies to contaminant and packaging investigations, the scientists of EAG support every phase of the product lifecycle.
- Composition & surface analysis: Analysis of layer structure and chemical composition, evaluation of particle size and composition, chemical imaging of drug and drug product, as well as the quantitation and distribution of active ingredients, excipients and coatings at the sub-micron scale
- cGMP analytical support: Analytical method development expertise and comprehensive analytical support for API and drug product, performed under phase-appropriate cGMP, including developmental and commercial stability, QC release testing and reference standard program management
- Investigative problem solving: Non-routine analytical testing services for pharmaceuticals, including reverse engineering, contaminant identification, black speck analysis, and material identification
- Trace analysis & structural chemistry: Multi-disciplinary expertise in the isolation, elucidation, identification and characterization of trace levels of knowns and unknowns for regulated and non-regulated studies, including contaminants in packaging, ingredients and final products, <USP 232/233> testing using ICP-MS, as well as full extractables and leachables programs
- Preclinical/clinical support (GLP): Method development and analytical support for IND-enabling ADME studies, including study design, dose preparation, mass balance determinations, metabolite profiling, and unknown metabolite identification
- Radiolabeling & custom synthesis (cGMP and R&D): Stable-label, radiolabel, custom synthesis, and reference standard synthesis under cGMP, 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
- Consulting & litigation support: EAG maintains a team of scientists and engineers who provide technical consulting, problem solving and litigation support, including expert testimony for patent violation investigations, product liability and other legal issues