EAG scientists have worked with virtually every class and type of generic drugs compound, across most indications and all common formulations. We have contributed data to and drafted sections of ANDA submissions and provided method remediation, commercial stability, QC release testing for dozens of generic drugs. 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 generic drugs to market smarter, faster and with less risk?
Turn to EAG. WE KNOW HOW.
HOW WE CAN HELP
EAG scientists support every phase of generic drug development and commercialization.
- Reverse engineering (deformulation): Physical and chemical analyses required to characterize active ingredients, product components and their degradants
- 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 level
- Chemistry, manufacturing & controls (cGMP): 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
- Contaminant ID/troubleshooting: Multi-disciplinary expertise in the isolation, elucidation, identification and characterization of trace levels of knowns and unknowns for regulated and non-regulated studies, including elemental contaminants in packaging, ingredients and final products, as well as full extractables and leachables programs, with ability to quantify elemental contaminants in packaging, ingredients and final products at ppm levels
- Radiolabeling & custom synthesis (cGMP and R&D): Stable-label, radiolabel, and custom synthesis of small and large molecule compounds and reference standards 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