Pharmaceutical Testing
Eurofins Regulatory Science Services’ scientific experts 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. From GLP and cGMP studies to contaminant and packaging investigations, together with the Eurofins Scientific Network, Eurofins Regulatory Science Services is ready to support every phase of your product's lifecycle.
Our pharmaceutical testing capabilities include:
- Environmental assessments: Evaluating a pharmaceutical product’s potential environmental impact requires expertise in both drug development and environmental testing. Eurofins' scientists are well versed in both. Our environmental risk assessment capabilities for human and veterinary pharmaceuticals provide the environmental data and guidance you need to meet testing and timing requirements. Eurofins offers a complete package of required product chemistry, ecotoxicology and environmental fate testing, including synthesis of 3H or 14C-labeled materials for metabolism studies.
- 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.
Additional services offered through the Eurofins Scientific Network:
- Composition & surface analysis: Analysis of layer structure and chemical composition; evaluation of particle size and composition; chemical imaging of drug and drug product; and 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.
- Specialized pharmaceutical services: Investigative problem solving, reverse engineering, contaminant identification, black speck analysis, and material identification.
- Trace analysis & structural chemistry: 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. We also offer <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.
Contact erssinfo@eurofins.com for more information!